The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Sirus Intramedullary Nail-femoral And Tibial Nails, Models 02.02631, 02.02651, 02.02652 Series.
Device ID | K043270 |
510k Number | K043270 |
Device Name: | SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Laura D Williams |
Correspondent | Laura D Williams ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-26 |
Decision Date | 2005-01-31 |
Summary: | summary |