The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Pelvic C-clamp.
| Device ID | K922796 |
| 510k Number | K922796 |
| Device Name: | PELVIC C-CLAMP |
| Classification | Component, Traction, Invasive |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Diane Cochet-wynant |
| Correspondent | Diane Cochet-wynant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-09 |
| Decision Date | 1994-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679398370 | K922796 | 000 |