ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE


Device Classification Name

cement, bone, vertebroplasty

510(k) Number K110183
Device Name ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
Applicant
ARTHROCARE CORP.
680 vaqueros ave.
sunnyvale, 
CA 
94085 -3523

Applicant Contact valerie defiesta-ng
Correspondent
ARTHROCARE CORP.
680 vaqueros ave.
sunnyvale, 
CA 
94085 -3523

Correspodent Contact valerie defiesta-ng
Regulation Number 888.3027
Classification Product Code
NDN  
Subsequent Product Codes
HXG   OAR  
Date Received 01/21/2011
Decision Date 02/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No