The following data is part of a premarket notification filed by Implanet, S.a. with the FDA for Jazz Pf.
| Device ID | K191217 |
| 510k Number | K191217 |
| Device Name: | JAZZ PF |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | Implanet, S.A. Technopole Bordeaux Montesquieu, Allee Francois Magendie Martillac, FR 33650 |
| Contact | Fabienne Larquey Cadiere |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1845 Market Street, Suite 230 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 | 2019-05-06 |
| Decision Date | 2019-08-02 |