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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 K202380
Device Name Born PT-LIF Cage HA
Applicant
Spineworxx AG
Schuppisstrasse 10
St. Gallen,  CH 9016
Applicant Contact Aouda Ouzzaa
Correspondent
Jalex Medical
27865 Clemens Rd.
Suite 3
Westlake,  OH  44145
Correspondent Contact Cassandra Petrov
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/20/2020
Decision Date 02/19/2021
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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