Camber Sacroiliac (SI) Fixation System— 510(k) K233972

Name: FDA 510(k) clearance K233972
Creator: U.S. Food and Drug Administration
Published: 2024-02-27

Substantially Equivalent

Camber Spine Technologies

FDA 510(k) clearance K233972 for Camber Sacroiliac (SI) Fixation System, Substantially Equivalent on 2024-02-27. Applicant: Camber Spine Technologies. Device class: 2.

Clearance details

Applicant: Camber Spine Technologies
Product code: Code OUR
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2023-12-15
Decision date: 2024-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: King Of Prussia, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUR

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K261381 — TiLink-L SI Joint Fusion System2026-08-24
K260477 — CATAMARAN SI Joint Fusion System2026-04-08
K253488 — iFuse INTRA Ti Implant System2026-02-11
K253611 — Falco Fusion System2026-01-29
K252834 — Sacroiliac Joint Truss System (SJTS)2026-01-28

More clearances from Camber Spine Technologies

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K234077 — SPIRA® Anterior Lumbar Spacers2024-07-12
K230942 — SPIRA® Posterior Lumbar Spacers2023-07-11
K221324 — ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)2023-03-30
K223837 — SPIRA®-C Integrated Fixation System2023-03-22
K220038 — Camber Spine Navigation System2022-04-29

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.