The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Flexible Humeral Nail(flex Nail) System.
Device ID | K972516 |
510k Number | K972516 |
Device Name: | SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM |
Classification | Nail, Fixation, Bone |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Angela Silvestri |
Correspondent | Angela Silvestri SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Product Code | JDS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-07 |
Decision Date | 1997-09-04 |
Summary: | summary |