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FDA 510(k)

b-ONE Total Knee System

K-Number: K180446 · 2018-10-12

ApplicantB-One Ortho, Corp.
Decision Date2018-10-12
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

b-ONE Total Knee 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 2018-10-12 under 510(k) number K180446. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the b-ONE Total Knee System?

b-ONE Total Knee System is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is B-One Ortho, Corp.. The 510(k) number is K180446.

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

b-ONE Total Knee System received FDA 510(k) clearance on 2018-10-12, under 510(k) number K180446.

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

The FDA product code for b-ONE Total Knee System is JWH.

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: JWH)

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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