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FDA 510(k)

SMR Shoulder System

K-Number: K161476 · 2016-06-24

ApplicantLima Corporate S.P.A.
Decision Date2016-06-24
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR Shoulder System is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2016-06-24 under approval number K161476. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMR Shoulder System?

SMR Shoulder System is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K161476.

When was SMR Shoulder System approved by the FDA?

SMR Shoulder System received FDA 510(k) clearance on 2016-06-24, under approval number K161476.

What company makes SMR Shoulder System?

SMR Shoulder System is manufactured by Lima Corporate S.P.A..

What is the FDA product code for SMR Shoulder System?

The FDA product code for SMR Shoulder System is KWT.

Related Clinical Trials

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Lima Corporate S.P.A.

K160011H-Max S stem K153722SMR 3-Pegs Glenoids K170473C2 femoral stem K163397SMR Hybrid Glenoid System K161120SMR TT Metal Back Glenoid, Bone Graft instruments K161226Revision Femoral Stem

View all 41 devices →

Related Devices (Code: KWT)

K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc. K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc. K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc. K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.

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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