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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 K221172
Device Name FOCUS Interbody System
Applicant
OC Medical Devices
15 East Montgomery Crossroads, Suite 3
Savannah,  GA  31406
Applicant Contact Jack Mathews
Correspondent
BackRoads Consulting Inc.
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/25/2022
Decision Date 10/14/2022
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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