X Spine Systems Inc

Product Numbers: 71088, 71692, 71708, 71750, 71761, 71781, 71807, 71849, 71881, 71090, 71693, 71709, 71751, 71762, 71787, 71808, 71850, 71882, 71092, 71694, 71710, 71752, 71763, 71789, 71809, 71851, 71885, 71682, 71695, 71711, 71753, 71764, 71791, 71810, 71857, 71886, 71686, 71696, 71712, 71755, 71765, 71793, 71811, 71858, 71889, 71687, 71698, 71716, 71756, 71766, 71795, 71813, 71859, 71893, 71688, 71700, 71746, 71757, 71767, 71797, 71814, 71873, 71894, 71689, 71701, 71747, 71758, 71768, 71799, 71815, 71874, 71896, 71690, 71705, 71748, 71759, 71769, 71801, 71816, 71877, 71897, 71691, 71707, 71749, 71760, 71780, 71806, 71817, 71878, 71899, 71900, 71937, 71957, 73417, 73427, 73440, 73453, 73470, 74073, 71903, 71939, 72184, 73418, 73428, 73441, 73454, 73471, 74097, 71904, 71940, 72419, 73419, 73429, 73445, 73455, 73472, 74098, 71907, 71943, 73409, 73420, 73430, 73446, 73456, 73760, 74099, 71908, 71944, 73411, 73421, 73431, 73447, 73464, 73761, 74100, 71911, 71947, 73412, 73422, 73433, 73448, 73465, 73762, 74101, 71912, 71948, 73413, 73423, 73435, 73449, 73466, 73763, 74102, 71915, 71952, 73414, 73424, 73437, 73450, 73467, 73886, 74103, 71916, 71953, 73415, 73425, 73438, 73451, 73468, 74047, 74104, 71936, 71956, 73416, 73426, 73439, 73452, 73469, 74072, 74105, 74107, 74125, 74143, 74293, 74305, 75280, 75297, 75307, 75317, 74108, 74127, 74144, 74294, 74306, 75282, 75299, 75308, 75318, 74109, 74129, 74285, 74295, 74307, 75283, 75300, 75309, 75319, 74110, 74131, 74286, 74296, 74432, 75284, 75301, 75310, 75320, 74111, 74132, 74287, 74299, 74987, 75285, 75302, 75311, 75321, 74112, 74134, 74288, 74300, 74991, 75287, 75303, 75312, 75322, 74116, 74135, 74289, 74301, 75248, 75289, 75304, 75313, 75323, 74119, 74137, 74290, 74302, 75273, 75291, 75305, 75314, 75324, 74121, 74139, 74291, 74303, 75276, 75293, 75305, 75315, 75333, 74123, 74141, 74292, 74304, 75278, 75295, 75306, 75316, 75334, 75335, 75355, 75376, 76369, 76536, 76593, 76602, 76613, 76639, 75336, 75358, 75377, 76370, 76537, 76593, 76603, 76614, 76640, 75337, 75360, 75379, 76372, 76538, 76594, 76605, 76615, 76642, 75338, 75362, 75382, 76374, 76540, 76595, 76606, 76616, 76737, 75344, 75364, 75384, 76375, 76542, 76596, 76607, 76618, 77253, 75346, 75365, 75386, 76376, 76588, 76597, 76608, 76619, 77260, 75346, 75367, 75588, 76377, 76589, 76598, 76609, 76621, 77261, 75350, 75370, 75798, 76406, 76590, 76599, 76610, 76629, 77262, 75351, 75372, 75802, 76407, 76591, 76600, 76611, 76630, 77263, 75353, 75375, 76139, 76534, 76592, 76601, 76612, 76638, 77264, 77265, 77811, 77852, 79382, 77266, 77815, 78174, 77267, 77817, 78175, 77270, 77820, 78176, 77322, 77823, 78518, 77647, 77851 and 79040.

Orthopedic Devices

2

Yes

Worldwide Distribution -- Including states of AZ, CA, CO, FL, ID, IN, MO, MS, NV, OK, TN, TX, UT and WY and countries of Spain, South Africa and the United Kingdom.

Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile. || The Capless LI Pedicle Screw System is indicated for the treatment of sever spondylolisthesis of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft.

Part numbers X079-0096 and X079-0097 with Lot #12320

General and Plastic Surgery Devices

1

No

US Distribution including the states of FL and MO.

Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.

Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050

General and Plastic Surgery Devices

1

No

Nationwide Distribution including CA, CO, FL, IA, IN, LA, NY, PA, TN, TX and UT.

Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 || The Axle Torque Driver Handle is used to lock the set screw into the locking plate.

Model #: N60001068; Lot #: 2943-01; Serial #s: 46118, 46581, 47296, 47588, 47653, 48164, 48201, 48412, 49156, 49585, 49586, 49649, G22, G45, G47, G77, G83, G87X, G90X, R15, XP03, XP21, XP27, XP28, XP29 & XP32.

Orthopedic Devices

2

Yes

Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.

Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400

Size, 28mm x 10mm x 6mm, Part #:, X034-0340, Lot #:, 118501, 23502, 23503, 24284, 24291, 24825, 24825s1, 24825S2, 760902; Size, 28mm x 10mm x 7mm, Part #:, X034-0341, Lot #:, 118502, 23504, 24285, 24826, 24826S1, 24826S2, 760903; Size, 28mm x 10mm x 8mm, Part #:, X034-0342, Lot #:, 118503, 23505, 24286, 24827, 24827S1, 24827S2, 760904; Size, 28mm x 10mm x 9mm, Part #:, X034-0343, Lot #:, 118504, 23506, 24287, 24828, 24828S1, 24828S2, 760905; Size, 28mm x 10mm x 10mm, Part #:, X034-0344, Lot #:, 118505, 23507, 24288, 24829, 24829S1, 24829S2, 760906; Size, 28mm x 10mm x 11mm, Part #:, X034-0345, Lot #:, 118506, 23508, 24289, 24830, 24830S1, 24830S2, 760907; Size, 28mm x 10mm x 12mm, Part #:, X034-0346, Lot #:, 118507, 23509, 24290, 24831, 24831S1, 24831s2, 760908; Size, 28mm x 10mm x 13mm, Part #:, X034-0347, Lot #:, 118508, 23510, 24291, 24832, 24832s1, 24832S2, 760909; Size, 28mm x 10mm x 14mm, Part #:, X034-0348, Lot #:, 118509, 23511, 24292, 24833, 760910; Size, 28mm x 10mm x 15mm, Part #:, X034-0349, Lot #:, 118510, 23512, 24293, 24293-R, 24834, 760911 & Size, 28mm x 10mm x 16mm, Part #:, X034-0350, Lot #:, 118511, 23513, 23514, 24294, 24835, 24835S1, 24835S2, 32513, 760912.

Orthopedic Devices

2

Yes

Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV. Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.

Calix T PEEK Lumbar System, TLIF Trial