MODIFICATION TO ISOLA SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K022285
Device Name MODIFICATION TO ISOLA SPINAL SYSTEM
Original Applicant
DEPUY ACROMED
325 paramount dr.
raynham, 
MA 
02767 -0350

Original Contact lisa gilman
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received 07/15/2002
Decision Date 08/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No