Device type
Sacroiliac Joint Fixation
Product code OUR · Class II · 21 CFR 888.3040 · Orthopedic
sacroiliac joint fusion
Recent 510(k)s
Oct 15, 2026
K262522
Odys-SI Screw
Medyssey Co, Ltd.
- OUR
- Class II
Aug 24, 2026
K261381
TiLink-L™ SI Joint Fusion System
SurGenTec, LLC
- OUR
- Class II
Recent recalls
Oct 21, 2026
Z-0146-2027
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
SI-BONE, Inc.
- OUR
- Class II
- Ongoing