The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Zimmer Natural Nail System Cephalomedullary Nails.
| Device ID | K091566 |
| 510k Number | K091566 |
| Device Name: | ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Daniel J Williman |
| Correspondent | Daniel J Williman 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 | 2009-05-28 |
| Decision Date | 2009-10-28 |
| Summary: | summary |