Orthopedic Devices

Yes

Non-active implants - bone surgery

Orthopedic Devices

Yes

Non-active implants - bone surgery

Orthopedic Devices

Yes

Non-active implants

Orthopedic Devices

Yes

Non-active implants - bone surgery

CATALOG NO. 9045-01, LOT #'s: 050709-8, 050809-C, 051209-D, 060209-A, 060809-C, 061709-C, 062009-0,  CATALOG NO. 9045-02, LOT #'s: 050809-B, 051309-8,060809-8, 061 709-0,060209-A

Orthopedic Devices

Unclassified

Yes

Nationwide Distribution including CO, CT, FL, KY, LA, MA, MO, NC, NY, OK, OR, TN, TX, VA & WI

PERPOS PLS, CATALOG #'s 9045-01 & 9045-02 || A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints.

CATALOG NO. 9045-01, LOT #'s: 050709-8, 050809-C, 051209-D, 060209-A, 060809-C, 061709-C, 062009-0,  CATALOG NO. 9045-02, LOT #'s: 050809-B, 051309-8,060809-8, 061 709-0,060209-A

Orthopedic Devices

Unclassified

Yes

Nationwide Distribution including CO, CT, FL, KY, LA, MA, MO, NC, NY, OK, OR, TN, TX, VA & WI

Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant || A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C.

All manuals; the manual were not coded.

Orthopedic Devices

Unclassified

Yes

Nationwide

Satellite Spinal System Primary User Group Reference Guide, 8 1/2 by 11 inch plastic binder, Medtronic Sofamor Danek, Medtronic, Memphis, TN 38132

All (US versions) guides/techniques; The Surgical Technique and Manual are not coded

Orthopedic Devices

Unclassified

Yes

Nationwide

Satellite Spinal System Surgical Technique, LITSATFUSST7-IRN10612/087, and LIT (DRAFT) Medtronic, Spinal and Biologics Business, Memphis, TN (this guide was originally a portion of the Satellite Spinal System Primary User Group Reference Guide a 8 1/2 by 11 inch plastic binder)

ALL LOTS to include: W05K0556, W05K1614, W06A3260

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 9 mm Satellite Sphere CoCr, Size 9 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000209, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0134, W05K0543, W05K0560, W05K0565, W05K1572, W05K1573, W05K1575

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 10 mm Satellite Sphere CoCr, Size 10 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000210, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0144, W05K0552, W05K0553, W05K0554, W05K0567, W05K0572, W05K0722

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 11 mm Satellite Sphere CoCr, Size 11 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000211, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0541, W05K0542, W05K0550, W05K0551, W05K0558, W05K0731, W06A0842

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 12 mm Satellite Sphere CoCr, Size 12 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000212, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0132, W05K0557, W05K1576, W05K1595, W05K2449, W06A0915

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 13 mm Satellite Sphere CoCr, Size 13 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000213, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0561, W05K0582, W05K1920, W06A2074, W07H0210

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 14 mm Satellite Sphere CoCr, Size 14 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000214, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0562, W05K0566, W05K1593, W06A2809

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 15 mm Satellite Sphere CoCr, Size 15 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 8000215, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: W05K0135, W05K0564, W05K1016, W06A1100

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, 16 mm Satellite Sphere CoCr, Size 16 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, REF 800021, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: LX52, MA67

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 10 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000210, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: LX53, LX59,MG73, MY47, MY49, NC36, ND61, NE27

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 11 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000211, Manufactured at: Warsaw, Indiana, USA

ALL LOTS to include: LX54, LX60, MA68, MG74, NB26, NE28, NF61

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 12 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000212, Manufactured at: Warsaw, Indiana, USA

part numbers: 497.087 497.088 497.089 497.093 497.094 497.095 497.098 497.099 497.100 497.225 497.226 497.227 497.228 497.229 497.230 497.231 497.232 497.233 497.234 497.235 497.236 497.237 497.238 497.239 497.241 497.242 497.243 497.244 497.245 497.246 497.247 497.248 497.249 lot numbers: 4550443 4938481 4947780 4947788 4955528 4955529 4955532 5830333 5830334 6005310 6011867 7371262 7371275 7424595 7459468 7613026 4814417 4884492 4938495 4947969 4955498 4955501 5770304 5830335 6011868 7371263 7459469 7613027 4686201 4814414 4938497 4938501 4938766 4947971 6011869 4362289 4393923 4816422 4935344 4938512 4938515 4938759 4947977 5767359 5770641 5812094 6011844 7371280 7423480 7613044 4362288 4816420 4938517 4938519 4938758 4947978 6024576 7371281 4362286 4816414 4816415 4938521 4938523 4938756 5811904 6011884 4362283 4562149 4617874 4816115 4816117 4884494 4938540 4947924 4947925 4955412 4955413 6005302 6011850 7371288 7844724 4362282 4685618 4698047 4816113 4938543 4938549 4947926 6011872 7371266 7423469 7544000 7613030 7775437 4362281 4393924 4685619 4816110 4938503 4938560 4947927 4947928 6011873 4362280 4393905 4550457 4568693 4617037 4686343 4686346 4694014 4694234 4755789 4755791 4755793 4821421 4882741 4882742 4882743 4882744 4947893 4947894 4947895 4947896 4947897 4947898 4947899 4947900 4969661 4969663 5816072 5857598 5883097 5883098 6031197 6031198 6079441 6087165 4362279 4393906 4550458 4568694 4617038 4686347 4686349 4686351 4694235 4709517 4755785 4755786 4755787 4821415 4882745 4882747 4882748 4938735 4947901 4947902 4947903 4947905 4947910 4969659 4969660 5642635 5702649 5744112 5744238 5883100 5883101 6011907 6024580 6087170 6087171 6087172 6087173 4362278 4393910 4550459 4617039 4686353 4694236 4709518 4755783 4755784 4821410 4882750 4882751 4882752 4882753 4938737 4947911 4947912 4947913 4969658 5668754 5697400 5770445 5857607 5872385 5883103 5883105 6021058 6024577 6031199 6031200 6063205 4362277 4550460 4568695 4617040 4686356 4694237 4755478 4755479 4755480 4821407 4882754 4882755 4882756 4882757 4947914 4947915 4947916 4947917 4947918 5426428 5770298 5839271 5857616 5883106 5883107 6016089 6031201 6031202 4568700 4617041 4686359 4694021 4694238 4755472 4755474 4755476 4821404 4882758 4882759 4882760 4882761 4947919 4947920 4947921 4969657 5839270 5872094 5872378 6024578 6031203 6031204 4362276 4686289 4697976 4755470 4755471 4885455 4947922 4947980 4947985 6011852 6031205 4362275 4550461 4686290 4938738 4947987 4947988 4947990 6011885 6031206 4362274 4686291 4697978 4755469 4885458 4938739 4947992 4947994 4947996 5407126 6030989 6030990 6031207 6052890 4362273 4697984 4755468 4885459 4938740 4947997 4947998 4948000 4948001 6011847 6031208 4686293 4820546 4885461 4938741 4948003 4948005 6011853 4362271 4686363 4755466 4755467 4885471 4948007 4948008 4948010 4948012 4969634 5365436 5668735 5668742 5680726 5872325 6009825 6016101 6031209 4362270 4393912 4686365 4695024 4820936 4885476 4938742 4938744 4948014 5407131 5407133 6011874 6031031 6031210 4686366 4695025 4755464 4820933 4820934 4885480 4938746 4948015 5407129 5407130 6031211 4362269 4686367 4695026 4755462 4820931 4820932 4938747 4948017 6011854 4686368 4820929 4948019 4948020 6011876 6024579 4362268 4617047 4686202 4814412 4885508 4948022 4948024 4969628 5642583 4686203 4885509 4948026 4948027 4969627 5759696 5835992 6011896 4208597 4686204 4885510 4938751 4947982 4948033 4948034 4969626 5505857 5505862 5816076 6011855 6367928 6882133 7544008 9807745 4362267 4617048 4885511 4938753 4947983 4947984 4947989 4969625 5767354 5770536 6005308 6011856 4362266 4885512 4938754 4938755 4947991 4947993 4969624 5682975 5770675 6011857 4208598 4938757 4938760 4938761 4938765 4947999 4948002 4948004 5770692 5812078 5812079 6011877 6087168 6367930 7599075 7613037 9807752 4362265 4816096 4938669 4938768 4948006 4948009 4969623 5835993 5891761 6005313 4362264 4816094 4885514 4938672 4948013 4969622 5649087 5744115 5816079 5835994 5861990 6011913 4208599 4617050 4695408 4816091 4816092 4885515 4938674 4948016 4948018 4948021 4969621 5767416 5770683 6005309 6011858 6052891 6916285 7404349 7544315

Orthopedic Devices

Unclassified

Yes

Worldwide distribution including US nationwide, Canada and Germany.

VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

ALL LOTS to include: LX55, LX61, MA69, MG75, NB27, ND62, NE29, NF62

Orthopedic Devices

Unclassified

Yes

Nationwide

Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 13 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000213, Manufactured at: Warsaw, Indiana, USA

SN 000242 SN 000244 SN 000246 SN 000247

Orthopedic Devices

Unclassified

Yes

US Distribution to the states of : PA, WV and CA.

Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 || The component in question is the hex driver (part number 2009-4001).

UDI 18257200125371, Lot Numbers: O02, O03 and O04

Orthopedic Devices

Unclassified

Yes

US

ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003

UDI 18257200125364, Lot Numbers: O01 and O02

Orthopedic Devices

Unclassified

Yes

US

ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002

Part Number 800-1212 lot # 1038452.

Orthopedic Devices

Unclassified

Yes

Nationwide Distribution including PA, TX, CA, IL IA, FL, CT, and MO

OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001