The following data is part of a premarket notification filed by Spineworks, Llc with the FDA for Fixxsure Cross Link.
| Device ID | K081331 |
| 510k Number | K081331 |
| Device Name: | FIXXSURE CROSS LINK |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| 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 | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-12 |
| Decision Date | 2008-07-23 |
| Summary: | summary |