LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X— 510(k) K082679

Name: FDA 510(k) clearance K082679
Creator: U.S. Food and Drug Administration
Published: 2009-04-07

Substantially Equivalent

Sintea Biotech, Inc.

FDA 510(k) clearance K082679 for LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X, Substantially Equivalent on 2009-04-07. 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: 2008-09-15
Decision date: 2009-04-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami Beach, FL, US

Download summary PDF View on FDA.gov ↗

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