SPINE SYSTEM EVOLUTION


information about

Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K001080
Device Name SPINE SYSTEM EVOLUTION
Original Applicant
AESCULAP, INC.
1000 gateway blvd.
south san francisco, 
CA 
94080

Original Contact lia s jones
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received 04/04/2000
Decision Date 06/29/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No