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B-One Ortho, Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K240528b-ONE® Total Hip SystemNovember 15, 2024
K222431b-ONER MOBIO Total Knee SystemOctober 6, 2022
K213673b-ONE MOBIO Total Knee SystemJanuary 21, 2022
K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix InNovember 4, 2021
K210483MOBIO Total Knee SystemApril 21, 2021
K202768KOSMO Femoral StemApril 1, 2021
K202429Mobio Total Knee SystemOctober 23, 2020
K182705Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System CupsFebruary 14, 2019
K183025MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System PaJanuary 28, 2019
K180446b-ONE Total Knee SystemOctober 12, 2018
K173380b-ONE® Total Hip SystemAugust 30, 2018