AMT POLYAXIAL PEDICLE SCREW


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K022768
Device Name AMT POLYAXIAL PEDICLE SCREW
Original Applicant
MICRON PRECISION ENGINEERING, INC.
939 evening shade dr.
san pedro, 
CA 
90731

Original Contact frank e bailey
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received 08/21/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No