A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K111166
Device Name A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
Applicant
SPINEWORKS, LLC
1001 oakwood blvd.
round rock, 
TX 
78681

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

Correspodent Contact j.d. webb
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 04/26/2011
Decision Date 09/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No