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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 K242303
Device Name MOD-C
Applicant
Orthomod, LLC
350 Fame Rd.
Dayton,  OH  45449
Applicant Contact David Kirschman
Correspondent
Empirical Technologies
350 Fame Rd.
Dayton,  OH  45449
Correspondent Contact David Kirschman
Regulation Number888.3080
Classification Product Code
ODP  
Date Received08/05/2024
Decision Date 04/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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