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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Driver, Wire, And Bone Drill, Manual
510(k) Number K212570
Device Name OsteoPlan System
Applicant
Osteomed, LLC
3885 Arapaho Rd.
Addison,  TX  75001
Applicant Contact Diane Rutherford
Correspondent
Osteomed, LLC
3885 Arapaho Rd.
Addison,  TX  75001
Correspondent Contact Diane Rutherford
Regulation Number872.4120
Classification Product Code
DZJ  
Subsequent Product Code
LLZ  
Date Received08/16/2021
Decision Date 02/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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