The following data is part of a premarket notification filed by Implanet S.a. with the FDA for Jazz System.
| Device ID | K143759 |
| 510k Number | K143759 |
| Device Name: | JAZZ System |
| 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 FL 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 | 2014-12-31 |
| Decision Date | 2015-05-07 |
| Summary: | summary |