The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Fastframe External Fixation System - Knee Spanning, Fastframe External Fixation System - Damage Control.
| Device ID | K151992 |
| 510k Number | K151992 |
| Device Name: | FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Patrick Mccullagh |
| 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 | 2015-07-20 |
| Decision Date | 2015-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024561991 | K151992 | 000 |
| 00889024561984 | K151992 | 000 |
| 00889024561977 | K151992 | 000 |
| 00889024508576 | K151992 | 000 |
| 00889024464094 | K151992 | 000 |
| 00889024464063 | K151992 | 000 |
| 00889024464056 | K151992 | 000 |