← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
OUR — Sacroiliac Joint Fixation
sacroiliac joint fusion
DEVICE CLASS
Class II
REGULATION
21 CFR 888.3040
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
20
510(K)/PMA CLEARANCES
510k: 20
0
RECALL ENTRIES
Recent clearances
K260477Tenon Medical · 510k2026-04-08
K253488SI-BONE, Inc. · 510k2026-02-11
K253611Mcnicoll Surgical, Inc. · 510k2026-01-29
K2528344Web Medical · 510k2026-01-28
K251365Si Solutions, LLC · 510k2025-11-20
K252322Genesys Spine · 510k2025-10-22
K253094SI-BONE, Inc. · 510k2025-10-09
K250894Eminent Spine · 510k2025-10-07
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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