MOSS MIAMI 6.35MM POLYAXIAL SCREW


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K992168
Device Name MOSS MIAMI 6.35MM POLYAXIAL SCREW
Applicant
DEPUY ACROMED
325 paramount dr.
raynham, 
MA 
02767 -0350

Applicant Contact frank maas
Correspondent
DEPUY ACROMED
325 paramount dr.
raynham, 
MA 
02767 -0350

Correspodent Contact frank maas
Regulation Number 888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received 06/28/1999
Decision Date 09/23/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No