The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Wristore Distal Radius Fracture Fixator, 4600 Series.
| Device ID | K042761 |
| 510k Number | K042761 |
| Device Name: | WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Noah Bartsch |
| Correspondent | Noah Bartsch ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-05 |
| Decision Date | 2004-11-17 |
| Summary: | summary |