The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Fastframe External Fixation System - Distal Radius.
| Device ID | K152484 |
| 510k Number | K152484 |
| Device Name: | FastFrame External Fixation System - Distal Radius |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ZIMMER, INC. 345 EAST MAIN STREET Warsaw, IN 46581 -0708 |
| Contact | Dorothy Snyder |
| Correspondent | Sujith M Kallur 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 | 2015-08-31 |
| Decision Date | 2015-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024464100 | K152484 | 000 |
| 00889024464070 | K152484 | 000 |