DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT— 510(k) K971742

Name: FDA 510(k) clearance K971742
Creator: U.S. Food and Drug Administration
Published: 1997-07-24

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K971742 for DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT, Substantially Equivalent on 1997-07-24. Applicant: Depuy, Inc.. Device class: 1.

Clearance details

Applicant: Depuy, Inc.
Product code: Code FMQ
Device class: Class 1
Regulation: 21 CFR 880.6760
Advisory panel: General Hospital
Date received: 1997-05-12
Decision date: 1997-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMQ

product code FMQ

Death: 8
Total: 8

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.