510(k) clearance
RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology
- 510(k) number
- K262193
- Applicant
- Xenix Medical
- Decision date
- Sep 14, 2026
- Date received
- Jun 29, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NKB
- Device type
- Thoracolumbosacral Pedicle Screw System
- Device class
- Class II
- Regulation
- 21 CFR 888.3070
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Orlando, FL, US