The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Combination Clamp And Dynamization Clip.
| Device ID | K973017 |
| 510k Number | K973017 |
| Device Name: | SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Contact | Kevin J O'connell |
| Correspondent | Kevin J O'connell SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-13 |
| Decision Date | 1997-10-16 |
| Summary: | summary |