SPIRA®-C Integrated Fixation System— 510(k) K223837

Substantially Equivalent

Camber Spine Technologies

FDA 510(k) clearance K223837 for SPIRA®-C Integrated Fixation System, Substantially Equivalent on 2023-03-22. Applicant: Camber Spine Technologies.

Clearance details

Applicant: Camber Spine Technologies
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2022-12-22
Decision date: 2023-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: King Of Prussia, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.