ROGOZINSKI SPINAL ROD SYSTEM SCREW— 510(k) K930298

Substantially Equivalent

Smith & Nephew Richards, Inc.

FDA 510(k) clearance K930298 for ROGOZINSKI SPINAL ROD SYSTEM SCREW, Substantially Equivalent on 1995-06-14. Applicant: Smith & Nephew Richards, Inc..

Clearance details

Applicant: Smith & Nephew Richards, Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1993-01-21
Decision date: 1995-06-14
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.