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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K120564
Device Name CALYPSO SYSTEM
Applicant
HOGAN LOVELLS US LLP
1835 MARKET ST 29TH FL
PHILADELPHIA,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
HOGAN LOVELLS US LLP
1835 MARKET ST 29TH FL
PHILADELPHIA,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received02/24/2012
Decision Date 07/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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