WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER— 510(k) K980496

Name: FDA 510(k) clearance K980496
Creator: U.S. Food and Drug Administration
Published: 1998-04-14

Substantially Equivalent for Some Indications

Wrightmedicaltechnologyinc

FDA 510(k) clearance K980496 for WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER, Substantially Equivalent for Some Indications on 1998-04-14. Applicant: Wrightmedicaltechnologyinc. Device class: 2.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 1998-02-09
Decision date: 1998-04-14
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

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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.