The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Matrixx System.
| Device ID | K171140 |
| 510k Number | K171140 |
| Device Name: | Matrixx System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Nexxt Spine LLC 14425 Bergen Blvd, Suite B Noblesville, IN 46060 |
| Contact | Andy Elsbury |
| Correspondent | Karen E. Warden BackRoads Consulting PO Box 566 Chesterland, OH 44026 -2141 |
| Product Code | ODP |
| Subsequent Product Code | MAX |
| Subsequent Product Code | MQP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-18 |
| Decision Date | 2017-08-22 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MATRIXX SYSTEM 74561345 1986551 Dead/Cancelled |
REAL COLORS HOLDINGS, INC. 1994-08-15 |