UNI-T UNI-THREAD SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K021510
Device Name UNI-T UNI-THREAD SPINAL SYSTEM
Original Applicant
SPINE VISION, INC
3003 summit blvd.
15th floor suite 1500
atlanta, 
GA 
30319

Original Contact lynnette whitaker
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
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