SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM


the company

Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K002733
Device Name SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
Original Applicant
DEPUY ACROMED
325 paramount dr.
raynham, 
MA 
02767 -0350

Original Contact frank mass
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received 09/01/2000
Decision Date 12/15/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No