MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K030383
Device Name MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
Applicant
DEPUY ACROMED
325 paramount dr.
raynham, 
MA 
02767 -0350

Applicant Contact lisa gilman
Correspondent
DEPUY ACROMED
325 paramount dr.
raynham, 
MA 
02767 -0350

Correspodent Contact lisa gilman
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received 02/05/2003
Decision Date 02/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No