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

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..

Clearance details

Applicant: Sintea Biotech, Inc.
Product code: Code JEC
Advisory panel: Orthopedic
Date received: 2008-09-15
Decision date: 2009-04-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami Beach, FL, US

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