The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Ncb Periprosthetic Trochanter Plates And Screws, Ncb Cable Button For Ncb Oplyaxial Locking Plate.
| Device ID | K120772 |
| 510k Number | K120772 |
| Device Name: | NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Romil Sheth |
| Correspondent | Romil Sheth ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HRS |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-14 |
| Decision Date | 2012-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024483668 | K120772 | 000 |
| 00889024289987 | K120772 | 000 |
| 00889024289994 | K120772 | 000 |
| 00889024290006 | K120772 | 000 |
| 00889024292673 | K120772 | 000 |
| 00889024292734 | K120772 | 000 |
| 00889024292796 | K120772 | 000 |
| 00889024292802 | K120772 | 000 |
| 00889024292819 | K120772 | 000 |
| 00889024292826 | K120772 | 000 |
| 00889024292963 | K120772 | 000 |
| 00889024298385 | K120772 | 000 |
| 00889024480001 | K120772 | 000 |
| 00889024480018 | K120772 | 000 |
| 00889024481169 | K120772 | 000 |
| 00889024289970 | K120772 | 000 |