The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Cable-ready Cable Grip System: Cable-ready Bone Plate System.
| Device ID | K151716 |
| 510k Number | K151716 |
| Device Name: | Cable-Ready Cable Grip System: Cable-Ready Bone Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46580 |
| Contact | Patrick Mccullagh |
| Correspondent | Dalene Binkley ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46580 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-25 |
| Decision Date | 2016-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024039582 | K151716 | 000 |
| 00889024039520 | K151716 | 000 |
| 00889024039490 | K151716 | 000 |
| 00889024039483 | K151716 | 000 |
| 00889024039476 | K151716 | 000 |
| 00889024039469 | K151716 | 000 |