The following data is part of a premarket notification filed by Implanet S.a. with the FDA for Jazz System.
| Device ID | K133617 |
| 510k Number | K133617 |
| Device Name: | JAZZ SYSTEM |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | IMPLANET S.A. 1835 MARKET ST. 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan IMPLANET S.A. 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 | 2013-11-25 |
| Decision Date | 2014-02-20 |
| Summary: | summary |