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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 Intervertebral Body
510(k) Number K000009
Device Name SPIRAL RADIUS RODDING SYSTEM
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Applicant Contact LUIS NESPRIDO
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Correspondent Contact LUIS NESPRIDO
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received01/03/2000
Decision Date 03/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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