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 |