STALIF (TM) C— 510(k) K072415

Substantially Equivalent

Surgicraft , Ltd.

FDA 510(k) clearance K072415 for STALIF (TM) C, Substantially Equivalent on 2008-01-25. Applicant: Surgicraft , Ltd..

Clearance details

Applicant: Surgicraft , Ltd.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2007-08-28
Decision date: 2008-01-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Douglassville, PA, US

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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.