HAND REAMERS— 510(k) K770203

Name: FDA 510(k) clearance K770203
Creator: U.S. Food and Drug Administration
Published: 1977-02-08

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K770203 for HAND REAMERS, Substantially Equivalent on 1977-02-08. Applicant: Depuy, Inc.. Device class: 1.

Clearance details

Applicant: Depuy, Inc.
Product code: Code HTO
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1977-01-31
Decision date: 1977-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTO

product code HTO

Injury: 404
Malfunction: 20,305
Total: 20,709

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.