EPOCA CODR STEM AND HEAD— 510(k) K014049

Substantially Equivalent

Stelkast Company

FDA 510(k) clearance K014049 for EPOCA CODR STEM AND HEAD, Substantially Equivalent on 2002-01-09. Applicant: Stelkast Company.

Clearance details

Applicant: Stelkast Company
Product code: Code KWT
Advisory panel: Orthopedic
Date received: 2001-12-10
Decision date: 2002-01-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Pittsburgh, PA, US

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Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.