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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 Integrated Fixation, Cervical
510(k) Number K222903
Device Name Tailored-H Cervical Stand Alone System
Applicant
Bespoke Technologies, LLC
118 S. Cherry St., Suite E
Winston-Salemn,  NC  27101
Applicant Contact Daniel Hoehn
Correspondent
Bespoke Technologies, LLC
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3080
Classification Product Code
OVE  
Date Received09/23/2022
Decision Date 11/18/2022
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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