CMC CABLE FIX


Device Classification Name

washer, bolt nut

510(k) Number K111032
Device Name CMC CABLE FIX
Applicant
INSTRATEK, INC.
4141 directors row
suite h
houston, 
TX 
77092

Applicant Contact jeff seavey
Correspondent
INSTRATEK, INC.
4141 directors row
suite h
houston, 
TX 
77092

Correspodent Contact jeff seavey
Regulation Number 888.3030
Classification Product Code
HTN  
Date Received 04/13/2011
Decision Date 08/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No