The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Cable-ready® Cable Grip System: Cable-ready Pin System, Cable-ready Needle System.
| Device ID | K151848 |
| 510k Number | K151848 |
| Device Name: | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System |
| Classification | Cerclage, Fixation |
| 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 | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-07 |
| Decision Date | 2016-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024039612 | K151848 | 000 |
| 00889024039605 | K151848 | 000 |
| 00889024434264 | K151848 | 000 |
| 00889024434257 | K151848 | 000 |
| 00889024434240 | K151848 | 000 |
| 00889024434233 | K151848 | 000 |