MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K021825
Device Name MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM
Original Applicant
UNITED STATES SURGICAL
150 glover ave.
norwalk, 
CT 
06856

Original Contact tina rideout
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received 06/04/2002
Decision Date 07/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No