The following data is part of a premarket notification filed by Spineworks, Llc with the FDA for A-wedge Anterior Interbody System (a-wedge A.i.s.).
| Device ID | K111166 |
| 510k Number | K111166 |
| Device Name: | A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINEWORKS, LLC 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb SPINEWORKS, LLC 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-26 |
| Decision Date | 2011-09-08 |
| Summary: | summary |