METALLIC RADIAL HEAD IMPLANTS— 510(k) K944507

Name: FDA 510(k) clearance K944507
Creator: U.S. Food and Drug Administration
Published: 1995-07-13

Substantially Equivalent for Some Indications

Wrightmedicaltechnologyinc

FDA 510(k) clearance K944507 for METALLIC RADIAL HEAD IMPLANTS, Substantially Equivalent for Some Indications on 1995-07-13. Applicant: Wrightmedicaltechnologyinc. Device class: 2.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code KWI
Device class: Class 2
Regulation: 21 CFR 888.3170
Advisory panel: Orthopedic
Date received: 1994-09-15
Decision date: 1995-07-13
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 KWI

product code KWI

Injury: 490
Total: 490

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.