SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X— 510(k) K022065

Name: FDA 510(k) clearance K022065
Creator: U.S. Food and Drug Administration
Published: 2002-08-06

Substantially Equivalent

Sintea Biotech, Inc.

FDA 510(k) clearance K022065 for SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X, Substantially Equivalent on 2002-08-06. Applicant: Sintea Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Sintea Biotech, Inc.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2002-06-25
Decision date: 2002-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

Download summary PDF View on FDA.gov ↗

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