OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System

Fastener, Fixation, Biodegradable, Soft Tissue

B-ONE ORTHO, Corp

The following data is part of a premarket notification filed by B-one Ortho, Corp with the FDA for Onefix Biocomposite Anchors, Onefix Biocomposite Small Anchors, Onefix All Suture Anchors, Onefix Interference Screws, Onefix Cannula System.

Pre-market Notification Details

Device IDK212912
510k NumberK212912
Device Name:OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant b-ONE ORTHO, Corp 3 Wing Drive Suite #259 Cedar Knolls,  NJ  07927
ContactAllison Gecik
CorrespondentAllison Gecik
b-ONE ORTHO, Corp 3 Wing Drive Suite #259 Cedar Knolls,  NJ  07927
Product CodeMAI  
Subsequent Product CodeHRX
Subsequent Product CodeHWC
Subsequent Product CodeMBI
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-13
Decision Date2021-11-04

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