The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cerclage Positioning Pin.
| Device ID | K992891 |
| 510k Number | K992891 |
| Device Name: | SYNTHES CERCLAGE POSITIONING PIN |
| Classification | Cerclage, Fixation |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-27 |
| Decision Date | 1999-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679498839S0 | K992891 | 000 |
| H679498837S0 | K992891 | 000 |
| H679498803S0 | K992891 | 000 |
| H679298839S0 | K992891 | 000 |
| H679298838S0 | K992891 | 000 |
| H679298837S0 | K992891 | 000 |
| H679298803S0 | K992891 | 000 |
| H679498838S0 | K992891 | 000 |