FDA 510(k)

BethaLoc® stem cementless HA

K-Number: K223103 · 2023-06-20

Decision Date2023-06-20

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BethaLoc® stem cementless HA is a medical device manufactured by Implantcast GmbH. It received FDA 510(k) clearance on 2023-06-20 under approval number K223103. 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 BethaLoc® stem cementless HA?

BethaLoc® stem cementless HA is a medical device that received FDA 510(k) clearance on 2023-06-20. It is manufactured by Implantcast GmbH. The 510(k) number is K223103.

When was BethaLoc® stem cementless HA approved by the FDA?

BethaLoc® stem cementless HA received FDA 510(k) clearance on 2023-06-20, under approval number K223103.

What company makes BethaLoc® stem cementless HA?

BethaLoc® stem cementless HA is manufactured by Implantcast GmbH.

What is the FDA product code for BethaLoc® stem cementless HA?

The FDA product code for BethaLoc® stem cementless HA is LZO.

Other Devices by Implantcast GmbH

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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.