The following data is part of a premarket notification filed by Trans1 Incorporated with the FDA for Trans1 Facet Screw.
| Device ID | K073515 |
| 510k Number | K073515 |
| Device Name: | TRANS1 FACET SCREW |
| Classification | System, Facet Screw Spinal Device |
| Applicant | TRANS1 INCORPORATED 411 LANDMARK DR. Wilmington, NC 28412 |
| Contact | William Jackson |
| Correspondent | William Jackson TRANS1 INCORPORATED 411 LANDMARK DR. Wilmington, NC 28412 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-14 |
| Decision Date | 2008-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815361020679 | K073515 | 000 |
| 00815361020242 | K073515 | 000 |
| 00815361020259 | K073515 | 000 |
| 00815361020266 | K073515 | 000 |
| 00815361020600 | K073515 | 000 |
| 00815361020617 | K073515 | 000 |
| 00815361020624 | K073515 | 000 |
| 00815361020631 | K073515 | 000 |
| 00815361020648 | K073515 | 000 |
| 00815361020655 | K073515 | 000 |
| 00815361020662 | K073515 | 000 |
| 00815361020235 | K073515 | 000 |