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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name growing rod system
510(k) Number K193224
Device Name Daytona® Small Stature Growth Rod Conversion Set
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad,  CA  92008
Applicant Contact Jesse Albright
Correspondent
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad,  CA  92008
Correspondent Contact Alicia McArthur
Regulation Number888.3070
Classification Product Code
PGM  
Date Received11/22/2019
Decision Date 02/13/2020
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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