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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7116046660 | K081331 | 000 |
| M7115537460 | K081331 | 000 |
| M7115536460 | K081331 | 000 |
| M7115531360 | K081331 | 000 |
| M7115528310 | K081331 | 000 |
| M71155280 | K081331 | 000 |
| M71155270 | K081331 | 000 |
| M71155260 | K081331 | 000 |
| M71155250 | K081331 | 000 |
| M71155240 | K081331 | 000 |
| M7115546660 | K081331 | 000 |
| M7115547660 | K081331 | 000 |
| M7116036460 | K081331 | 000 |
| M7116031360 | K081331 | 000 |
| M7116028310 | K081331 | 000 |
| M71160280 | K081331 | 000 |
| M71160270 | K081331 | 000 |
| M71160260 | K081331 | 000 |
| M71160250 | K081331 | 000 |
| M71160240 | K081331 | 000 |
| M71160230 | K081331 | 000 |
| M71155230 | K081331 | 000 |