Integra LifeSciences Corp

510K #: K981262 Device Listing #: D001100 Item Number C4601S Lot #: 1112631 Lot #: 1112632 Lot #: 1112633 Lot #: 1112634 Lot #: 1112635 Lot #1113361

General and Plastic Surgery Devices

Unclassified

No

Worldwide Distribution

Integra CUSA EXcel Sterile Tips Rx Only || Single Use Only || Product Usage: For usage in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.

2.5 cc Part numbers - IOS10125 Lot numbers - N199416 and 215944  5 cc Part numbers - lOS10155 Lot numbers - 208500, 206504 and N216026

Orthopedic Devices

2

Yes

Nationwide Distribution - Including the states of CA, OK, MD and VA.

Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect), Integra OS Putty is resorbed and replaced with bone during the healing process.

MPM, CAMO1, PAC1 :  MEF1100103;MED1102303; MEB1101602; MEF1100203; MEC1100602;MED1101003; MED1102203; MEE1102003; MED1102103; MEC1102302; MEB1101402; MEE1101003; MEF1100703; MEE1101903; MEF1101103; MEB1100803; MEC1103002; MEE1100903; MED1101703; MED1101203; MEC1102902; MEB1101103; MEC1102002; MEB1101502; MED1102203; MEF1100603; MEE1101203; MEC1100102; MEE1101503; MEE1100703; MEF1100403; MED1101303; MED1101403; MEF1100303; MEC1100702; MED1101103; MEC1102402; MEC1101602; MEF1100903; MEE1101303; MED1102003; MEC1103302; MEE1101803; MEE1100803; MEF1100503; MEC1102502; MEC1101702; MEE1101403; MEC1103402; MEF1100803; MEC1102802; MEC1101802;MEF1101003; MEC1103102; MEC1101902; MEC1102102

Neurological Devices

2

No

Worldwide Distribution-- USA (nationwide ) .

Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors

Catalog number: 7CBD10, lot numbers: 1057983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630, and 0161857.

Neurological Devices

1

No

Nationwide, Canada, Taiwan and to Integra, Australia.

Integra NeuroSciences Implants, NeuroBalloon Catheter, || Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10

Catalog Number DURS3391; Lot number 1091575

Neurological Devices

2

Yes

Nationwide distribution:Ca, NY, TX, CO, VA, SC, IA, MO, IL, LA, OR, OH, WI, FL, DC, DE, MD, MN.

Suturable DuraGen Dural Regeneration Matrix; || Non-Pyrogenic; || Sterility guaranteed unless package is damaged or opened. Rx only. || Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536 || Suturable DuraGen is an absorbable implant for repair of dural defects. It is indicated as a dural substitute for the repair of dura matter.