SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X


Device Classification Name

component, traction, invasive

510(k) Number K022065
Device Name SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
Original Applicant
SINTEA BIOTECH, INC.
407 lincoln rd. suite 10l
miami beach, 
FL 
33139

Original Contact marianne grunwaldt
Regulation Number 888.3040
Classification Product Code
JEC  
Date Received 06/25/2002
Decision Date 08/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No