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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, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K182705
Device Name Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
Applicant
b-ONE Ortho Corp.
3 Wing Drive Suite #259
Cedar Knolls,  NJ  07927
Applicant Contact Allison Gecik
Correspondent
b-ONE Ortho Corp.
3 Wing Drive Suite #259
Cedar Knolls,  NJ  07927
Correspondent Contact Allison Gecik
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received09/27/2018
Decision Date 02/14/2019
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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