The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Proximal Femoral Nail (pfn) System.
Device ID | K970097 |
510k Number | K970097 |
Device Name: | PROXIMAL FEMORAL NAIL (PFN) SYSTEM |
Classification | Pin, Fixation, Threaded |
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 | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-13 |
Decision Date | 1997-03-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H679030101150 | K970097 | 000 |
H6793570390 | K970097 | 000 |