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 |