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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K021825
Device Name MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM
Applicant
Unitedstates Surgical
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact TINA RIDEOUT
Correspondent
Unitedstates Surgical
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact TINA RIDEOUT
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received06/04/2002
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
Predetermined Change
Control Plan Authorized		 No
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