The following data is part of a premarket notification filed by Implanet S.a. with the FDA for Jazz Frame System.
| Device ID | K162764 |
| 510k Number | K162764 |
| Device Name: | JAZZ FRAME SYSTEM |
| 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 HOGANLOVELLS US LLP 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-30 |
| Decision Date | 2017-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607503507554 | K162764 | 000 |
| 03607503507226 | K162764 | 000 |
| 03607503507233 | K162764 | 000 |
| 03607503507271 | K162764 | 000 |
| 03607503507509 | K162764 | 000 |
| 03607503507516 | K162764 | 000 |
| 03607503507523 | K162764 | 000 |
| 03607503507530 | K162764 | 000 |
| 03607503507547 | K162764 | 000 |
| 03607503507219 | K162764 | 000 |