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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 K213219
Device Name Vy Spine™ VyWasher™ Buttress System
Applicant
Vy Spine, LLC
2236 Capital Cir. NE, Suite 103-1
Tallahassee,  FL  32308
Applicant Contact Jordan Hendrickson
Correspondent
Vy Spine, LLC
2236 Capital Cir. NE, Suite 103-1
Tallahassee,  FL  32308
Correspondent Contact Jordan Hendrickson
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/29/2021
Decision Date 12/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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