CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM— 510(k) K021549

Substantially Equivalent

Std Mfg., Inc.

FDA 510(k) clearance K021549 for CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM, Substantially Equivalent on 2002-08-01. Applicant: Std Mfg., Inc..

Clearance details

Applicant: Std Mfg., Inc.
Product code: Code KXA
Advisory panel: Orthopedic
Date received: 2002-05-13
Decision date: 2002-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, MA, US

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Adverse events under product code KXA

product code KXA

Injury: 324
Total: 324

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.