FACET FIXX
System, Facet Screw Spinal Device
NEXXT SPINE LLC
The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Facet Fixx.
Pre-market Notification Details
| Device ID | K131417 |
| 510k Number | K131417 |
| Device Name: | FACET FIXX |
| Classification | System, Facet Screw Spinal Device |
| Applicant | NEXXT SPINE LLC 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden Phd |
| Correspondent | Karen E Warden Phd NEXXT SPINE LLC 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-16 |
| Decision Date | 2013-07-12 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889929011614 | K131417 | 000 |
| 00889929011607 | K131417 | 000 |
| 00889929011591 | K131417 | 000 |
| 00889929011584 | K131417 | 000 |
| 00889929011577 | K131417 | 000 |
| 00889929011560 | K131417 | 000 |
Trademark Results [FACET FIXX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FACET FIXX 86169603 4596493 Live/Registered |
Nexxt Spine, LLC 2014-01-19 |
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