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FDA 510(k)

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups

K-Number: K182705 · 2019-02-14

ApplicantB-One Ortho, Corp.
Decision Date2019-02-14
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups is a medical device manufactured by B-One Ortho, Corp.. It received FDA 510(k) clearance on 2019-02-14 under approval number K182705. 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 Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups?

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups is a medical device that received FDA 510(k) clearance on 2019-02-14. It is manufactured by B-One Ortho, Corp.. The 510(k) number is K182705.

When was Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups approved by the FDA?

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups received FDA 510(k) clearance on 2019-02-14, under approval number K182705.

What company makes Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups?

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups is manufactured by B-One Ortho, Corp..

What is the FDA product code for Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups?

The FDA product code for Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups is LZO.

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Related PubMed Literature

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Other Devices by B-One Ortho, Corp.

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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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