The following data is part of a premarket notification filed by Trans1, Inc. with the FDA for Trans1 Trans-sacral Spinal Access And Preparation Kit.
| Device ID | K032891 |
| 510k Number | K032891 |
| Device Name: | TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT |
| Classification | Arthroscope |
| Applicant | TRANS1, INC. 6285 CHASKA ROAD Excelsior, MN 55331 |
| Contact | W. Allen Putnam |
| Correspondent | W. Allen Putnam TRANS1, INC. 6285 CHASKA ROAD Excelsior, MN 55331 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-17 |
| Decision Date | 2004-01-15 |
| Summary: | summary |