The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Cable Ready Cable Grip System Cable Button.
| Device ID | K091799 |
| 510k Number | K091799 |
| Device Name: | CABLE READY CABLE GRIP SYSTEM CABLE BUTTON |
| Classification | Washer, Bolt Nut |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Anthony Francalancia |
| Correspondent | Anthony Francalancia ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-17 |
| Decision Date | 2009-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024084995 | K091799 | 000 |
| 00889024084988 | K091799 | 000 |
| 00889024084971 | K091799 | 000 |