DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K112724
Device Name DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
Applicant
MEDOS INTERNATIONAL SARL
325 paramount drive
raynham, 
MA 
02767

Applicant Contact eugene bang
Correspondent
MEDOS INTERNATIONAL SARL
325 paramount drive
raynham, 
MA 
02767

Correspodent Contact eugene bang
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 09/19/2011
Decision Date 11/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No