TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)— 510(k) K946348

Substantially Equivalent for Some Indications

Sofamor Danek USA,Inc.

FDA 510(k) clearance K946348 for TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS), Substantially Equivalent for Some Indications on 1995-08-07. Applicant: Sofamor Danek USA,Inc..

Clearance details

Applicant: Sofamor Danek USA,Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1994-12-30
Decision date: 1995-08-07
Decision: Substantially Equivalent for Some Indications
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.