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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Femoral, Resurfacing
510(k) Number K201219
Device Name Biocore9 Femoral Head Resurfacing Component
Applicant
Biocore9, LLC
9 Whippany Rd., Bldg. A1, Unit 12
Whippany,  NJ  07981
Applicant Contact Stan Matlak
Correspondent
Biocore9, LLC
9 Whippany Rd., Bldg. A1, Unit 12 A
Whippany,  NJ  07981
Correspondent Contact Steve Peoples
Regulation Number888.3400
Classification Product Code
KXA  
Date Received05/06/2020
Decision Date 01/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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