The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Natural Nail System Tibial Nail And Stainless Steel Tibial Nail.
| Device ID | K130595 |
| 510k Number | K130595 |
| Device Name: | ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Stephen H Mckelvey |
| Correspondent | Stephen H Mckelvey ZIMMER, INC. 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 | 2013-03-07 |
| Decision Date | 2013-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024063020 | K130595 | 000 |
| 00889024063013 | K130595 | 000 |
| 00889024485440 | K130595 | 000 |
| 00889024485433 | K130595 | 000 |
| 00889024485426 | K130595 | 000 |