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FDA 510(k)

b-ONE® Total Hip System

K-Number: K173380 · 2018-08-30

ApplicantB-One Ortho, Corp.
Decision Date2018-08-30
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

b-ONE® Total Hip System is a medical device manufactured by B-One Ortho, Corp.. It received FDA 510(k) clearance on 2018-08-30 under approval number K173380. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the b-ONE® Total Hip System?

b-ONE® Total Hip System is a medical device that received FDA 510(k) clearance on 2018-08-30. It is manufactured by B-One Ortho, Corp.. The 510(k) number is K173380.

When was b-ONE® Total Hip System approved by the FDA?

b-ONE® Total Hip System received FDA 510(k) clearance on 2018-08-30, under approval number K173380.

What company makes b-ONE® Total Hip System?

b-ONE® Total Hip System is manufactured by B-One Ortho, Corp..

What is the FDA product code for b-ONE® Total Hip System?

The FDA product code for b-ONE® Total Hip System is LZO.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by B-One Ortho, Corp.

K180446b-ONE Total Knee System K182705Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups K183025MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component K202429Mobio Total Knee System K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System K210483MOBIO Total Knee System

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Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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