AMT SPINAL SYSTEM


definition

Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K002059
Device Name AMT SPINAL SYSTEM
Original Applicant
MICRON PRECISION ENGINEERING, INC.
939 evening shade dr.
san pedro, 
CA 
90731

Original Contact frank e baily
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNH  
Date Received 07/06/2000
Decision Date 11/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No