The following data is part of a premarket notification filed by Implanet, S.a. with the FDA for Jazz Lock.
| Device ID | K153348 |
| 510k Number | K153348 |
| Device Name: | JAZZ LOCK |
| Classification | Bone Fixation Cerclage, Sublaminar |
| 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 | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-20 |
| Decision Date | 2016-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981188436 | K153348 | 000 |
| 10889981188429 | K153348 | 000 |
| 10889981188146 | K153348 | 000 |