The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Ncb Plating System, Proximal Tibia Plates.
| Device ID | K061211 |
| 510k Number | K061211 |
| Device Name: | NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Anthony Francalancia |
| Correspondent | Anthony Francalancia ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-01 |
| Decision Date | 2006-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024491953 | K061211 | 000 |
| 00889024292536 | K061211 | 000 |
| 00889024292529 | K061211 | 000 |
| 00889024292505 | K061211 | 000 |
| 00889024292499 | K061211 | 000 |
| 00889024292482 | K061211 | 000 |
| 00889024290280 | K061211 | 000 |
| 00889024298347 | K061211 | 000 |
| 00889024298330 | K061211 | 000 |
| 00889024292543 | K061211 | 000 |
| 00889024292567 | K061211 | 000 |
| 00889024491946 | K061211 | 000 |
| 00889024292635 | K061211 | 000 |
| 00889024292628 | K061211 | 000 |
| 00889024292611 | K061211 | 000 |
| 00889024292604 | K061211 | 000 |
| 00889024292598 | K061211 | 000 |
| 00889024292581 | K061211 | 000 |
| 00889024292574 | K061211 | 000 |
| 00889024298323 | K061211 | 000 |