FDA 510(k)

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

Numéro K : K262341 · 2026-09-08

Date de décision2026-09-08

Code produitJWH

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : JWH)

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Source officielle

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