DRILLING TEMPLATE— 510(k) K853761

Name: FDA 510(k) clearance K853761
Creator: U.S. Food and Drug Administration
Published: 1985-10-07

Substantially Equivalent

Orthopedic Systems, Inc.

FDA 510(k) clearance K853761 for DRILLING TEMPLATE, Substantially Equivalent on 1985-10-07. Applicant: Orthopedic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code GEY
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1985-09-09
Decision date: 1985-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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K910031 — PARK CITY SHOULDER POSITIONER1991-01-24
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Adverse events under product code GEY

product code GEY

Malfunction: 7,488
Total: 7,488

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.