INTERMEDICS ORTHOPEDICS SAW BLADE— 510(k) K931210

Name: FDA 510(k) clearance K931210
Creator: U.S. Food and Drug Administration
Published: 1993-11-18

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K931210 for INTERMEDICS ORTHOPEDICS SAW BLADE, Substantially Equivalent on 1993-11-18. Applicant: Intermedics Orthopedics. Device class: 1.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code GFA
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1993-03-10
Decision date: 1993-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GFA

product code GFA

Death: 2
Injury: 140
Malfunction: 2,337
Total: 2,479

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.