BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR THE AFFINITY® Anterior Cervical Cage System:

The AFFINITY® Anterior Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. AFFINITY® implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The AFFINITY® Anterior Cervical Cage System should not be implanted in patients with an active infection or with an allergy to titanium or titanium alloy.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.

Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, definition of DDD, and other important medical information.

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