The following data is part of a premarket notification filed by Implanet, S.a. with the FDA for Jazz Claw System (hooks And Rods) And Jazz Claw Connector.
| Device ID | K160226 |
| 510k Number | K160226 |
| Device Name: | JAZZ CLAW System (hooks And Rods) And JAZZ CLAW Connector |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Implanet, S.A. Technopole Bordeaux Montesquieu, Allee Francois Magendie Martillac, FR 33650 |
| Contact | Regis Le Couedic |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1835 Market St., 29th Floor Philadelphia, PA 19103 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| Subsequent Product Code | OWI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-29 |
| Decision Date | 2016-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607505500577 | K160226 | 000 |
| 03607505503370 | K160226 | 000 |
| 03607505503387 | K160226 | 000 |
| 03607505503394 | K160226 | 000 |
| 03607505503400 | K160226 | 000 |
| 03607503507103 | K160226 | 000 |
| 03607503507110 | K160226 | 000 |
| 03607503507127 | K160226 | 000 |
| 03607503507134 | K160226 | 000 |
| 03607503507158 | K160226 | 000 |
| 03607503507165 | K160226 | 000 |
| 03607503507172 | K160226 | 000 |
| 03607503507189 | K160226 | 000 |
| 03607505503356 | K160226 | 000 |