SRRS PRESSED FIT FEMORAL REVISION COMPONENT— 510(k) K960908

Substantially Equivalent

Stelkast Company

FDA 510(k) clearance K960908 for SRRS PRESSED FIT FEMORAL REVISION COMPONENT, Substantially Equivalent on 1996-08-08. Applicant: Stelkast Company.

Clearance details

Applicant: Stelkast Company
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 1996-03-05
Decision date: 1996-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.