SUB-TALAR LOK, MODEL 7-11 MM


Device Classification Name

screw, fixation, bone

510(k) Number K080280
Device Name SUB-TALAR LOK, MODEL 7-11 MM
Applicant
INSTRATEK, INC.
210 spring hill dr.
suite 130
the woodlands, 
TX 
77386

Applicant Contact jeff seavey
Correspondent
INSTRATEK, INC.
210 spring hill dr.
suite 130
the woodlands, 
TX 
77386

Correspodent Contact jeff seavey
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 02/04/2008
Decision Date 03/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No