SPIRA-C Open Matrix Cervical Interbody— 510(k) K172446

Substantially Equivalent

Camber Spine Technologies

FDA 510(k) clearance K172446 for SPIRA-C Open Matrix Cervical Interbody, Substantially Equivalent on 2017-11-07. Applicant: Camber Spine Technologies.

Clearance details

Applicant: Camber Spine Technologies
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2017-08-14
Decision date: 2017-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.