OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K111326
Device Name OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM
Applicant
GRAHAM MEDICAL TECHNOLOGIES, L.L.C.
611 west 5th street,
third floor
austin, 
TX 
78701

Applicant Contact julie powell
Correspondent
GRAHAM MEDICAL TECHNOLOGIES, L.L.C.
611 west 5th street,
third floor
austin, 
TX 
78701

Correspodent Contact julie powell
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 05/11/2011
Decision Date 07/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No