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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, cervical
510(k) Number K211501
Device Name Advantage-C PEEK Cervical lnterbody Fusion Device
Applicant
lntelivation, LLC
70 Gruber Lane
Saint Simons Island,  GA  31522
Applicant Contact Jack Griffis
Correspondent
lntelivation, LLC
70 Gruber Lane
Saint Simons Island,  GA  31522
Correspondent Contact Jack Griffis
Regulation Number888.3080
Classification Product Code
ODP  
Date Received05/14/2021
Decision Date 08/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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