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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K212912
Device Name OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
Applicant
B-One Ortho, Corp.
3 Wing Dr., Suite 259
Cedar Knolls,  NJ  07927
Applicant Contact Allison Gecik
Correspondent
B-One Ortho, Corp.
3 Wing Dr., Suite 259
Cedar Knolls,  NJ  07927
Correspondent Contact Allison Gecik
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Codes
HRX   HWC   MBI  
Date Received09/13/2021
Decision Date 11/04/2021
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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