MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM

Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K071376
Device Name MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
Applicant
VERTEBRON, INC.
400 long beach blvd.
stratford, 
CT 
06615

Applicant Contact luis nesprido
Correspondent
VERTEBRON, INC.
400 long beach blvd.
stratford, 
CT 
06615

Correspodent Contact luis nesprido
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received 05/17/2007
Decision Date 06/13/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No