CROSS-OVER ACETABULAR SHELL & LINER— 510(k) K122773

Substantially Equivalent

Stelkast Company

FDA 510(k) clearance K122773 for CROSS-OVER ACETABULAR SHELL & LINER, Substantially Equivalent on 2012-10-09. Applicant: Stelkast Company.

Clearance details

Applicant: Stelkast Company
Product code: Code OQG
Advisory panel: Orthopedic
Date received: 2012-09-10
Decision date: 2012-10-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Mcmurray, PA, US

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Adverse events under product code OQG

product code OQG

Injury: 249
Total: 249

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.