The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Ncb Periprosthetic Femur Polyaxial Locking Plate System.
| Device ID | K112174 |
| 510k Number | K112174 |
| Device Name: | NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-28 |
| Decision Date | 2011-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024289949 | K112174 | 000 |
| 00889024289932 | K112174 | 000 |
| 00889024289925 | K112174 | 000 |
| 00889024289918 | K112174 | 000 |
| 00889024289901 | K112174 | 000 |
| 00889024289895 | K112174 | 000 |
| 00889024289888 | K112174 | 000 |
| 00889024288683 | K112174 | 000 |
| 00889024288676 | K112174 | 000 |