FixxSure® X-Link
Orthosis, Spondylolisthesis Spinal Fixation
INNOVASIS, INC.
The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Fixxsure® X-link.
Pre-market Notification Details
| Device ID | K162143 |
| 510k Number | K162143 |
| Device Name: | FixxSure® X-Link |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
| Contact | Marshall Mccarty |
| Correspondent | Marshall Mccarty INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2016-09-23 |
| Summary: | summary |
Trademark Results [FixxSure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIXXSURE 77858763 3923949 Live/Registered |
INNOVASIS, INC. 2009-10-27 |
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