HA GLOBAL TAPER (GT) TAPERED HIP STEM— 510(k) K970337

Substantially Equivalent

Smith & Nephew, Inc., Orthopaedic Div.

FDA 510(k) clearance K970337 for HA GLOBAL TAPER (GT) TAPERED HIP STEM, Substantially Equivalent on 1997-02-28. Applicant: Smith & Nephew, Inc., Orthopaedic Div..

Clearance details

Applicant: Smith & Nephew, Inc., Orthopaedic Div.
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 1997-01-29
Decision date: 1997-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.