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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 the device name listed in this FDA 510(k) record. The listed applicant is B-One Ortho, Corp.. It received FDA 510(k) clearance on 2018-08-30 under 510(k) 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. The listed applicant is B-One Ortho, Corp.. The 510(k) number is K173380.

When did b-ONE® Total Hip System receive FDA 510(k) clearance?

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

Who is the listed applicant for b-ONE® Total Hip System?

The FDA 510(k) record lists B-One Ortho, Corp. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing B-One Ortho, Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253357b-ONE® Bipolar HeadK240528b-ONE® Total Hip SystemK222431b-ONER MOBIO Total Knee SystemK213673b-ONE MOBIO Total Knee SystemK212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula SystemK210483MOBIO Total Knee System

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Related Devices (Code: LZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

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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