The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short.
| Device ID | K120715 |
| 510k Number | K120715 |
| Device Name: | ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Stephen H Mckelvey |
| Correspondent | Stephen H Mckelvey ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-08 |
| Decision Date | 2012-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024276444 | K120715 | 000 |
| 00889024276451 | K120715 | 000 |
| 00889024276437 | K120715 | 000 |
| 00889024276420 | K120715 | 000 |
| 00889024276383 | K120715 | 000 |
| 00889024276376 | K120715 | 000 |
| 00889024276369 | K120715 | 000 |
| 00889024276352 | K120715 | 000 |
| 00889024276345 | K120715 | 000 |
| 00889024276338 | K120715 | 000 |
| 00889024276321 | K120715 | 000 |
| 00889024276314 | K120715 | 000 |
| 00889024276307 | K120715 | 000 |
| 00889024276291 | K120715 | 000 |
| 00889024276277 | K120715 | 000 |
| 00889024276253 | K120715 | 000 |
| 00889024276246 | K120715 | 000 |
| 00889024276468 | K120715 | 000 |
| 00889024276499 | K120715 | 000 |
| 00889024298781 | K120715 | 000 |
| 00889024298736 | K120715 | 000 |
| 00889024298682 | K120715 | 000 |
| 00889024298637 | K120715 | 000 |
| 00889024298613 | K120715 | 000 |
| 00889024298606 | K120715 | 000 |
| 00889024298590 | K120715 | 000 |
| 00889024298583 | K120715 | 000 |
| 00889024298576 | K120715 | 000 |
| 00889024298569 | K120715 | 000 |
| 00889024276697 | K120715 | 000 |
| 00889024276666 | K120715 | 000 |
| 00889024276659 | K120715 | 000 |
| 00889024276642 | K120715 | 000 |
| 00889024276604 | K120715 | 000 |
| 00889024276598 | K120715 | 000 |
| 00889024276222 | K120715 | 000 |