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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, Lumbar
510(k) Number K222009
Device Name aprevo® anterior lumbar interbody fusion device with interfixation
Applicant
Carlsmed, Inc.
1800 Aston Ave.
Ste. 100
Carlsbad,  CA  92008
Applicant Contact Karen Liu
Correspondent
Carlsmed, Inc.
1800 Aston Ave.
Ste. 100
Carlsbad,  CA  92008
Correspondent Contact Karen Liu
Regulation Number888.3080
Classification Product Code
OVD  
Date Received07/07/2022
Decision Date 11/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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