KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT— 510(k) K030237

Name: FDA 510(k) clearance K030237
Creator: U.S. Food and Drug Administration
Published: 2003-08-29

Substantially Equivalent

Kapp Surgical Instrument, Inc.

FDA 510(k) clearance K030237 for KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT, Substantially Equivalent on 2003-08-29. Applicant: Kapp Surgical Instrument, Inc.. Device class: 2.

Clearance details

Applicant: Kapp Surgical Instrument, Inc.
Product code: Code KWI
Device class: Class 2
Regulation: 21 CFR 888.3170
Advisory panel: Orthopedic
Date received: 2003-01-23
Decision date: 2003-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warrensville, OH, 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.