FuseForce™ Flex Dynamic Compression System
Staple, Fixation, Bone
Wright Medical
The following data is part of a premarket notification filed by Wright Medical with the FDA for Fuseforce™ Flex Dynamic Compression System.
Pre-market Notification Details
| Device ID | K203832 |
| 510k Number | K203832 |
| Device Name: | FuseForce™ Flex Dynamic Compression System |
| Classification | Staple, Fixation, Bone |
| Applicant | Wright Medical 1023 Cherry Road Memphis, TN 38117 |
| Contact | Jonathan Dimotta |
| Correspondent | Jonathan Dimotta Wright Medical 1023 Cherry Road Memphis, TN 38117 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-30 |
| Decision Date | 2021-05-07 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797103541 | K203832 | 000 |
| 00889797103411 | K203832 | 000 |
| 00889797103428 | K203832 | 000 |
| 00889797103435 | K203832 | 000 |
| 00889797103442 | K203832 | 000 |
| 00889797103459 | K203832 | 000 |
| 00889797103466 | K203832 | 000 |
| 00889797103473 | K203832 | 000 |
| 00889797103480 | K203832 | 000 |
| 00889797103497 | K203832 | 000 |
| 00889797103503 | K203832 | 000 |
| 00889797103510 | K203832 | 000 |
| 00889797103527 | K203832 | 000 |
| 00889797103534 | K203832 | 000 |
| 00889797103404 | K203832 | 000 |
Trademark Results [FuseForce]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FUSEFORCE 85807798 4433891 Live/Registered |
Solana Surgical, LLC 2012-12-20 |
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