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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 K213355
Device Name Toro-L Interbody Fusion System
Applicant
Integrity Implants, Inc.
354 Hiatt Dr.
Palm Beach Gardens,  FL  33418
Applicant Contact Alexa Kamer
Correspondent
Integrity Implants, Inc.
354 Hiatt Dr.
Palm Beach Gardens,  FL  33418
Correspondent Contact Alexa Kamer
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
PHM  
Date Received10/12/2021
Decision Date 03/25/2022
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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