TSRH SPINAL SCREWS— 510(k) K932029

Substantially Equivalent

Sofamor Danek Mfg., Inc.

FDA 510(k) clearance K932029 for TSRH SPINAL SCREWS, Substantially Equivalent on 1995-01-20. Applicant: Sofamor Danek Mfg., Inc..

Clearance details

Applicant: Sofamor Danek Mfg., Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1993-04-27
Decision date: 1995-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.