The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Nexxt Matrixx System.
Device ID | K193412 |
510k Number | K193412 |
Device Name: | NEXXT MATRIXX System |
Classification | Spinal Vertebral Body Replacement Device - 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 |
Product Code | PLR |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-09 |
Decision Date | 2020-02-24 |