ADAPTIVE WEDGE


Device Classification Name

plate, fixation, bone

510(k) Number K110662
Device Name ADAPTIVE WEDGE
Applicant
ADAPTIVE SPECIALTY, LLC
1001 oakwood blvd
round rock, 
TX 
78681

Applicant Contact j.d. webb
Correspondent
ADAPTIVE SPECIALTY, LLC
1001 oakwood blvd
round rock, 
TX 
78681

Correspodent Contact j.d. webb
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 03/08/2011
Decision Date 03/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No