FDA 510(k)

b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions

K-Nummer: K262341 · 2026-09-08

Entscheidungsdatum2026-09-08

ProduktcodeJWH

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions 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 2026-09-08 under 510(k) number K262341. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions?

b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions is a medical device that received FDA 510(k) clearance on 2026-09-08. The listed applicant is B-One Ortho, Corp.. The 510(k) number is K262341.

When did b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions receive FDA 510(k) clearance?

b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions received FDA 510(k) clearance on 2026-09-08, under 510(k) number K262341.

Who is the listed applicant for b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions?

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® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions?

The FDA product code for b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions is JWH.

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Weitere Einträge mit B-One Ortho, Corp. als Antragsteller

K253357b-ONE® Bipolar Head K240528b-ONE® Total Hip System K222431b-ONER MOBIO Total Knee System K213673b-ONE MOBIO Total Knee System K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System K210483MOBIO Total Knee System

Alle 13 Geräte anzeigen →

Verwandte Geräte (Code: JWH)

K262057GMK ExtensionMedacta International SA K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262130ATTUNE Revision KniegelenkssystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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