CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES— 510(k) K882469

Substantially Equivalent

Orthoconcept, Inc.

FDA 510(k) clearance K882469 for CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES, Substantially Equivalent on 1988-12-01. Applicant: Orthoconcept, Inc..

Clearance details

Applicant: Orthoconcept, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1988-06-15
Decision date: 1988-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, SC, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.