DANEK TISSUE CUTTING AND REMOVAL SYSTEM— 510(k) K922486

Substantially Equivalent for Some Indications

Sofamor Danek Mfg., Inc.

FDA 510(k) clearance K922486 for DANEK TISSUE CUTTING AND REMOVAL SYSTEM, Substantially Equivalent for Some Indications on 1993-10-12. Applicant: Sofamor Danek Mfg., Inc..

Clearance details

Applicant: Sofamor Danek Mfg., Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1992-05-27
Decision date: 1993-10-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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.