MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K022190
Device Name MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
Original Applicant
DEPUY ACROMED
325 paramount dr.
raynham, 
MA 
02767 -0350

Original Contact karen f jurczak
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received 07/05/2002
Decision Date 07/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No