The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Cable-ready® Cable Grip System: Cable-ready® Gtr System, Cable-ready® 1.8mm Cerclage Cables.
| Device ID | K151907 |
| 510k Number | K151907 |
| Device Name: | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| 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 | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-13 |
| Decision Date | 2015-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024039537 | K151907 | 000 |
| 00889024039513 | K151907 | 000 |
| 00889024039438 | K151907 | 000 |
| 00889024039377 | K151907 | 000 |
| 00889024039339 | K151907 | 000 |
| 00889024039315 | K151907 | 000 |
| 00889024039360 | K151907 | 000 |