REVOLVE ADDITIONAL IMPLANTS


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K111449
Device Name REVOLVE ADDITIONAL IMPLANTS
Applicant
GLOBUS MEDICAL, INC.
2560 general armistead ave.
valley forge business center
audubon, 
PA 
19403

Applicant Contact sarah marie fitzgerald
Correspondent
GLOBUS MEDICAL, INC.
2560 general armistead ave.
valley forge business center
audubon, 
PA 
19403

Correspodent Contact sarah marie fitzgerald
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received 05/25/2011
Decision Date 08/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No