The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Fastframe External Fixation System-ankle Spanning.
| Device ID | K152755 |
| 510k Number | K152755 |
| Device Name: | FastFrame External Fixation System-Ankle Spanning |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Zimmer, Inc. 345 East Main Street Warsaw, IN 46580 |
| Contact | Dorothy Snyder |
| Correspondent | Sujith M. Kallur Zimmer, Inc. P.O. Box 708 Warsaw, IN 46851 -0708 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-24 |
| Decision Date | 2015-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024464117 | K152755 | 000 |
| 00889024464087 | K152755 | 000 |
| 00889024616356 | K152755 | 000 |