The following data is part of a premarket notification filed by Implanet, S.a. with the FDA for Jazz System.
| Device ID | K151740 |
| 510k Number | K151740 |
| 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 Floor Philadephia, 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 | 2015-06-26 |
| Decision Date | 2015-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607505502953 | K151740 | 000 |
| 03607505512969 | K151740 | 000 |
| 03607505512952 | K151740 | 000 |
| 03607505503189 | K151740 | 000 |
| 03607505503172 | K151740 | 000 |
| 03607505503165 | K151740 | 000 |
| 03607505503141 | K151740 | 000 |
| 03607505503134 | K151740 | 000 |
| 03607505503127 | K151740 | 000 |
| 03607505503004 | K151740 | 000 |
| 03607505502991 | K151740 | 000 |
| 03607505502984 | K151740 | 000 |
| 03607505512976 | K151740 | 000 |
| 03607503501507 | K151740 | 000 |
| 03607503501538 | K151740 | 000 |
| 03607505500591 | K151740 | 000 |
| 03607505500560 | K151740 | 000 |
| 03607503502122 | K151740 | 000 |
| 03607503502108 | K151740 | 000 |
| 03607503502085 | K151740 | 000 |
| 03607503502061 | K151740 | 000 |
| 03607503502047 | K151740 | 000 |
| 03607503502023 | K151740 | 000 |
| 03607503502009 | K151740 | 000 |
| 03607503501583 | K151740 | 000 |
| 03607503501545 | K151740 | 000 |
| 03607505500614 | K151740 | 000 |