The following data is part of a premarket notification filed by Adaptive Specialty, Llc with the FDA for Fusion Advantage Cervical Cage, Fusion Advantage Lumbar Cage.
| Device ID | K083425 |
| 510k Number | K083425 |
| Device Name: | FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | ADAPTIVE SPECIALTY, LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb ADAPTIVE SPECIALTY, LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-19 |
| Decision Date | 2009-03-20 |
| Summary: | summary |