The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 2nd Generation Pelvic C-clamp.
| Device ID | K071476 |
| 510k Number | K071476 |
| Device Name: | SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP |
| Classification | Component, Traction, Invasive |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Angela Silvestri |
| Correspondent | Angela Silvestri SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-29 |
| Decision Date | 2007-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679033060110 | K071476 | 000 |
| H679033060100 | K071476 | 000 |
| H679033060080 | K071476 | 000 |
| H679033060030 | K071476 | 000 |
| H679033060020 | K071476 | 000 |
| H679033060010 | K071476 | 000 |
| H679033060000 | K071476 | 000 |
| H679023060070 | K071476 | 000 |
| H679023060060 | K071476 | 000 |