SURGICRAFT SCREW FIXATION SYSTEM


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K080447
Device Name SURGICRAFT SCREW FIXATION SYSTEM
Applicant
SURGICRAFT LTD.
111 hill road
douglassville, 
PA 
19518

Applicant Contact donald w guthner
Correspondent
SURGICRAFT LTD.
111 hill road
douglassville, 
PA 
19518

Correspodent Contact donald w guthner
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 02/19/2008
Decision Date 06/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No