The following data is part of a premarket notification filed by Implanet, S.a. with the FDA for Jazz Passer Band.
| Device ID | K171881 |
| 510k Number | K171881 |
| Device Name: | JAZZ Passer Band |
| 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 1835 MARKET STREET, 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 | 2017-06-23 |
| Decision Date | 2017-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607503502603 | K171881 | 000 |
| 03607503502580 | K171881 | 000 |
| 03607503502566 | K171881 | 000 |
| 03607503501576 | K171881 | 000 |