SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K030103
Device Name SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS
Original Applicant
DEPUY ACROMED
325 paramount dr.
raynham, 
MA 
02767 -0350

Original Contact frank mass
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received 01/13/2003
Decision Date 02/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No