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FDA 510(k)

Revision Femoral Stem

K-Number: K161226 · 2017-02-10

ApplicantLima Corporate S.P.A.
Decision Date2017-02-10
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Revision Femoral Stem is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2017-02-10 under approval number K161226. 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 Revision Femoral Stem?

Revision Femoral Stem is a medical device that received FDA 510(k) clearance on 2017-02-10. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K161226.

When was Revision Femoral Stem approved by the FDA?

Revision Femoral Stem received FDA 510(k) clearance on 2017-02-10, under approval number K161226.

What company makes Revision Femoral Stem?

Revision Femoral Stem is manufactured by Lima Corporate S.P.A..

What is the FDA product code for Revision Femoral Stem?

The FDA product code for Revision Femoral Stem is LZO.

Related Clinical Trials

NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT07571408 Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive Disease NOT_YET_RECRUITING NCT04090359 Dual Mobility Acetabular Cups in Revision TJA RECRUITING

Other Devices by Lima Corporate S.P.A.

K160011H-Max S stem K161476SMR Shoulder System K153722SMR 3-Pegs Glenoids K170473C2 femoral stem K163397SMR Hybrid Glenoid System K161120SMR TT Metal Back Glenoid, Bone Graft instruments

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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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