MODIFICATION TO MONARCH SPINE SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K023438
Device Name MODIFICATION TO MONARCH SPINE SYSTEM
Original Applicant
DEPUY ACROMED
325 paramount dr.
raynham, 
MA 
02767 -0350

Original Contact lisa gilman
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received 10/15/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No