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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K201755
Device Name WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad,  CA  92008
Applicant Contact Aly Alvarez
Correspondent
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad,  CA  92008
Correspondent Contact Aly Alvarez
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
PHM  
Date Received06/29/2020
Decision Date 12/15/2020
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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