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 |