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 |