The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Natural Nail System Piriformis Fossa And Greater Trochanter Antegrade Femoral Nails.
| Device ID | K083497 |
| 510k Number | K083497 |
| Device Name: | ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ZIMMER, INC. 345 E. MAIN ST. Warsaw, IN 46580 |
| Contact | Carol Vierling |
| Correspondent | Carol Vierling ZIMMER, INC. 345 E. MAIN ST. Warsaw, IN 46580 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-25 |
| Decision Date | 2009-02-19 |
| Summary: | summary |