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FDA 510(k)

SP-CL Hip Stem and LCU Hip System

K-Number: K213770 · 2022-09-13

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2022-09-13
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SP-CL Hip Stem and LCU Hip System is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2022-09-13 under approval number K213770. 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 SP-CL Hip Stem and LCU Hip System?

SP-CL Hip Stem and LCU Hip System is a medical device that received FDA 510(k) clearance on 2022-09-13. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K213770.

When was SP-CL Hip Stem and LCU Hip System approved by the FDA?

SP-CL Hip Stem and LCU Hip System received FDA 510(k) clearance on 2022-09-13, under approval number K213770.

What company makes SP-CL Hip Stem and LCU Hip System?

SP-CL Hip Stem and LCU Hip System is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for SP-CL Hip Stem and LCU Hip System?

The FDA product code for SP-CL Hip Stem and LCU Hip System is LZO.

Other Devices by Waldemar Link GmbH & Co. KG

K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated K171273LINK® BiMobile(TM) Dual Mobility System K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System) K190535BiMobile Dual Mobility System - E-Dur Inserts K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)

View all 29 devices →

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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