Integra LifeSciences Corp.

Model #'s: 21-11-2708, 21-21-2710, 21-23-3510, 21-40-0110, 21-LT-3508, 21-11-2710, 21-21-2712, 21-23-3512, 21-40-0120, 21-LT-3510, 21-11-2712, 21-21-2714, 21-23-3514, 21-40-0130, 21-LT-3512, 21-11-3108, 21-21-2716, 21-23-3516, 21-40-0131, 21-LT-3514, 21-11-3110, 21-21-3108, 21-23-3908, 21-40-0135, 21-LT-3516, 21-11-3112, 21-21-3110, 21-23-3910, 21-40-0140, 21-LT-3908, 21-11-3114, 21-21-3112, 21-23-3912, 21-40-0150, 21-LT-3910, 21-11-3116, 21-21-3114, 21-23-3914, 21-40-0160, 21-LT-3912, 21-11-3508, 21-21-3116, 21-23-3916, 21-40-0165, 21-LT-3914, 21-11-3510, 21-21-3508, 21-24-2708, 21-40-0170, 21-LT-3916, 21-11-3512, 21-21-3510, 21-24-2710, 21-40-0180, 21-TA-2708, 21-11-3514, 21-21-3512, 21-24-2712, 21-40-0190, 21-TA-2710, 21-11-3516, 21-21-3514, 21-24-2714, 21-40-0190-3, 21-TA-2712, 21-11-3908, 21-21-3516, 21-24-2716, 21-40-0200, 21-TA-2714, 21-11-3910, 21-21-3908, 21-24-3108, 21-40-0215, 21-TA-2716, 21-11-3912, 21-21-3910, 21-24-3110, 21-40-0245, 21-TA-3108, 21-11-3914, 21-21-3912, 21-24-3112, 21-40-0290, 21-TA-3110, 21-11-3916, 21-21-3914, 21-24-3114, 21-40-0400, 21-TA-3112, 21-20-2708, 21-21-3916, 21-24-3116, 21-40-0500, 21-TA-3114, 21-20-2710, 21-22-3112, 21-24-3508, 21-50-0100, 21-TA-3116, 21-20-2712, 21-22-3114, 21-24-3510, 21-50-0110, 21-TA-3508, 21-20-2714, 21-22-3116, 21-24-3512, 21-50-0210, 21-TA-3510, 21-20-2716, 21-22-3512, 21-24-3514, 21-50-0310, 21-TA-3512, 21-20-3108, 21-22-3514, 21-24-3516, 21-50-0410, 21-TA-3514, 21-20-3110, 21-22-3516, 21-24-3908, 21-99-0001, 21-TA-3516, 21-20-3112, 21-22-3912, 21-24-3910, 21-99-0002, 21-TA-3908, 21-20-3114, 21-22-3914, 21-24-3912, 21-99-0002-2-1, 21-TA-3910, 21-20-3116, 21-22-3916, 21-24-3914, 21-99-0002-3-1, 21-TA-3912, 21-20-3508, 21-23-2708, 21-24-3916, 21-99-0002-3-2, 21-TA-3914, 21-20-3510, 21-23-2710, 21-25-3112, 21-LT-2708, 21-TA-3916, 21-20-3512, 21-23-2712, 21-25-3114, 21-LT-2710, 21-XT-3112, 21-20-3514, 21-23-2714, 21-25-3116, 21-LT-2712, 21-XT-3114, 21-20-3516, 21-23-2716, 21-25-3512, 21-LT-2714, 21-XT-3116, 21-20-3908, 21-23-3108, 21-25-3514, 21-LT-2716, 21-XT-3512, 21-20-3910, 21-23-3110, 21-25-3516, 21-LT-3108, 21-XT-3514, 21-20-3912, 21-23-3112, 21-25-3912, 21-LT-3110, 21-XT-3516, 21-20-3914, 21-23-3114, 21-25-3914, 21-LT-3112, 21-XT-3912, 21-20-3916, 21-23-3116, 21-25-3916, 21-LT-3114, 21-XT-3914, 21-21-2708, 21-23-3508, 21-40-0100, 21-LT-3116 & 21-XT-3916.

Orthopedic Devices

2

Yes

Nationwide Distribution -- AL, AZ, CA, CT, ID, KS, MO, NH, NV, NY, OH, OK, TX & UT.

Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and instruments required for a procedure. Also packaged as individual instruments and implants in poly bags distributed as replenishment for surgical kits. Theken Spine, LLC, Akron, OH 44306. || Indicated for use as an adjunct for fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.

Ref IP2P, Lot number: 250210A; Serial Numbers: 833, 834, 835, 836, 837, 838, 839, 841, 844, 846, 847, 848, 850, 851, 852, 853, 854, 855, 857, 858, 859, 860, 861, 862, 864.

Neurological Devices

2

No

Worldwide Distribution: USA, including the states of FL, ID, IL, and NJ, and the countries of Argentina and Costa Rica.

Licox Brain PMO Probe Kit; || Ref IP2.P; || Multiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP2 Bolt kit for 2 brain probes, Ref CC1.P1 combined Oxygen & Temperature probe; || Contains sterile and non-pyrogenic if package is unopened and undamaged. || Integra US, 311 Enterprise Drive, Plainsboro, NJ 08536

lot code 326081; and lot code 327081.

Orthopedic Devices

1

No

Nationwide Distribution

Integra Ruggles Surgical Instrument ACF Distraction Screws || Sterile, Rx only || Catalog number R6357A (12 mm), Catalog number R6397A (16 mm), || Integra LifeSciences Corp., 311 Enterprise Drive, Plainsboro, NJ 08536

Catalog number: 903-430, Lot Numbers 148792, 149247; Catalog Number 903-435, Lot Numbers 147796, 148790; Catalog Number 903-440; and Lot Numbers 147795, 149246

Neurological Devices

2

Yes

Worldwide Distribution - MI, IL, NY, IN, CA, IN and NC and Carnegie, Victoria, Melbourne, Australia.

Gravity Compensating Accessory; || High Pressure Range, Sterile, Single Use, Rx only. CSF shunt accessory. || Manufacturer: Integra Neuro Sciences Implants, SA, Cedex, France; || distributed by: Integra NeuroSciences, Plainsboro, NJ 08536 || The GCA is an implantable device designed to be used in conjunction with implanted systems which shunt cerebrospinal fluid CSF from the cerebral ventricles to an appropriate drainage site.

Lot 050-779, Model # 1523211; Lot 050-779, Model # 1523215.

General and Plastic Surgery Devices

Unclassified

No

The product is distributed directly to the firm''s sales representatives and direct accounts.

Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set.