PLUS PIVOT LINK UNIVERSAL SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K021507
Device Name PLUS PIVOT LINK UNIVERSAL SYSTEM
Original Applicant
SPINE VISION, INC
3003 summit blvd.
15th floor suite 1500
atlanta, 
GA 
30319

Original Contact lynnette whitaker
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received 05/09/2002
Decision Date 08/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No