HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM— 510(k) K030198

Name: FDA 510(k) clearance K030198
Creator: U.S. Food and Drug Administration
Published: 2003-04-01

Substantially Equivalent

Hand Innovations, Inc.

FDA 510(k) clearance K030198 for HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM, Substantially Equivalent on 2003-04-01. Applicant: Hand Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Hand Innovations, Inc.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2003-01-21
Decision date: 2003-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Hand Innovations, Inc.

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K050932 — DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM2005-04-26
K042059 — SHOULDER FIXATION SYSTEM2004-09-30
K041157 — MODIFICATION TO SMALL BONE FIXATION SYSTEM2004-07-30
K041081 — FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES2004-07-01
K033406 — SMALL BONE FIXATION SYSTEM2004-01-15

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.