The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Proximal Femoral Nail(pfn) System Modification.
Device ID | K973240 |
510k Number | K973240 |
Device Name: | SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION |
Classification | Pin, Fixation, Smooth |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Contact | Sheri L Musgnung |
Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-28 |
Decision Date | 1997-11-20 |
Summary: | summary |