FDA 510(k)

implaFit® hip stems

K-Number: K210678 · 2022-08-17

Decision Date2022-08-17

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

implaFit® hip stems is a medical device manufactured by Implantcast GmbH. It received FDA 510(k) clearance on 2022-08-17 under approval number K210678. 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 implaFit® hip stems?

implaFit® hip stems is a medical device that received FDA 510(k) clearance on 2022-08-17. It is manufactured by Implantcast GmbH. The 510(k) number is K210678.

When was implaFit® hip stems approved by the FDA?

implaFit® hip stems received FDA 510(k) clearance on 2022-08-17, under approval number K210678.

What company makes implaFit® hip stems?

implaFit® hip stems is manufactured by Implantcast GmbH.

What is the FDA product code for implaFit® hip stems?

The FDA product code for implaFit® hip stems is LZO.

Other Devices by Implantcast GmbH

K163577Ecofit® Hip System K180263EcoFit Vit E Acetabular System K191569Implantcast ic-Bipolar Head System K181778MUTARS Proximal Femur Replacement System K191433AGILON® XO Shoulder Replacement System K200045MUTARS Cemented Femoral Stems

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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.