CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM— 510(k) K023096

Substantially Equivalent

Std Mfg., Inc.

FDA 510(k) clearance K023096 for CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM, Substantially Equivalent on 2003-04-10. Applicant: Std Mfg., Inc..

Clearance details

Applicant: Std Mfg., Inc.
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 2002-09-18
Decision date: 2003-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, MA, US

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Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.