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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 K213456
Device Name Xenco Medical Multilevel CerviKit
Applicant
Xenco Medical, LLC
9930 Mesa Rim Rd.
San Diego,  CA  92121 -2910
Applicant Contact Jason Haider
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy Suite 120
Woodstock,  GA  30188
Correspondent Contact Linda Braddon
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/26/2021
Decision Date 12/21/2021
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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