MITEK 2GII MENISCAL REPAIR SYSTEM


the company

Device Classification Name

fastener, fixation, biodegradable, soft tissue

510(k) Number K002406
Device Name MITEK 2GII MENISCAL REPAIR SYSTEM
Original Applicant
MITEK PRODUCTS
249 vanderbilt ave.
norwood, 
MA 
02062

Original Contact carol chaoui
Regulation Number 888.3030
Classification Product Code
MAI  
Subsequent Product Codes
GAM   GAS  
Date Received 08/07/2000
Decision Date 02/15/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No