SOFAMOR ORTHOPAEDIC INSTRUMENTS— 510(k) K933242

Substantially Equivalent

Danek Medical, Inc.

FDA 510(k) clearance K933242 for SOFAMOR ORTHOPAEDIC INSTRUMENTS, Substantially Equivalent on 1994-01-28. Applicant: Danek Medical, Inc..

Clearance details

Applicant: Danek Medical, Inc.
Product code: Code LXH
Advisory panel: Orthopedic
Date received: 1993-07-02
Decision date: 1994-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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Adverse events under product code LXH

product code LXH

Death: 11
Injury: 2,218
Malfunction: 31,318
Total: 33,547

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.