Accessories for the Captiva Spine FuseLOX Lumbar Cage. || The FuseLOX Lumbar Inserter product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. || Inserter products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. || FPT - F is FuseLOX, P is Plif, and I is Inserter. || Products subject to recall: FuseLOX Lumbar Inserter || Inserter - Part Number: FPT0200 Lot Number 6110100. || Quantity distributed (8) is found in table on page 5 of 6. || The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1***Material: PEEK-OPTIMA LT1, Tantalum ASTM F560***Non-Sterile-Single Use Only (See package insert for sterilization parameters and labeling.)***CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.***Manufactured and distributed by: CAPTIVA SPINE***captivaspine.com***967 Alternate A1A #1 Jupiter, FL 33477 Tel: 877-772-5571 Fax: 866-318-3224 Email: info@captivaspine.com***" || FPC - F is FuseLOX, P is Plif, C is Convex || Products subject to recall: || Convex - 7mm x 25mm Part Number: FPC2507 Lot Number 07110002. || Convex - 8 mm x 25mm Part Number FPC2508 Lot Number 07110003. || Convex - 9mm x 25mm Part Number: FPC2509 Lot Number 07110004. || Convex - 10mm x 25mm Part Number: FPC2510 Lot Number 07110005. || Convex - 11mm x 25mm Part Number: FPC2511 Lot Number 07110006. || Convex - 12mm x 25mm Part Number: FPC2512 Lot Number 07110007. || Convex - 13mm x 25mm Part Number FPC2513 Lot Number 07110008. || Convex - 14mm x 25mm Part Number FPC2514 Lot Number 07110009. || Products are packaged individually and shipped as replacement parts to be placed in the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. || The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1***Material: PEEK-OPTIMA LT1, Tantalum ASTM F560***Non-Sterile-Single Use Only (See package insert for sterilization parameters and labeling.)***CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.***Manufactured and distributed by: CAPTIVA SPINE***captivaspine.com***967 Alternate A1A #1 Jupiter, FL 33477 Tel: 877-772-5571 Fax: 866-318-3224 Email: info@captivaspine.com***" || FPL - F is FuseLOX, P is Plif, C is Lorditic || Products subject to recall: FuseLOX Lumbar Lorditic: || Lorditic - 7mm x 25mm Part Number: FPL2507 Lot Number 07110010. || Lorditic - 8mm x 25mm Part Number FPL2508 Lot Number 07110011. || Lorditic - 9mm x 25mm Part Number: FPL2509 Lot Number 07110012. || Lorditic - 10mm x 25mm Part Number: FPL2510 Lot Number 07110013. || Lorditic - 11mm x 25mm Part Number: FPL2511 Lot Number 07110014. || Lorditic - 12mm x 25mm Part Number: FPL2512 Lot Number 07110015. || Lorditic - 13mm x 25mm Part Number FPL2513 Lot Number 07110016. || Products are packaged individually and shipped as replacement parts to be placed in the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. || The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Accessories for the Captiva Spine FuseLOX Lumbar Cage. || The Trial product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. || Trial products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. || FPT - F is FuseLOX, P is Plif, and T is Trial. || Products subject to recall: FuseLOX Lumbar Trials || Trial - 7mm x 25mm Part Number: FPT2507 Lot Number 8110001. || Trial - 8mm x 25mm Part Number FPT2508 Lot Number 8110002. || Trial - 9mm x 25mm Part Number: FPT2509 Lot Number 8110003. || Trial - 10mm x 25mm Part Number: FPT2510 Lot Number 8110004. || Trial - 11mm x 25mm Part Number: FPT2511 Lot Number 8110005. || Trial - 12mm x 25mm Part Number: FPT2512 Lot Number 8110006. || Trial - 13mm x 25mm Part Number FPT2513 Lot Number 8110007. || Trial - 14mm x 25mm Part Number FPT2514 Lot Number 8110008. || The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.