Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EVOS Large Fragment Plating System

K-Number: K201918 · 2020-11-16

ApplicantSmith & Nephew, Inc.
Decision Date2020-11-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOS Large Fragment Plating System is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2020-11-16 under approval number K201918. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOS Large Fragment Plating System?

EVOS Large Fragment Plating System is a medical device that received FDA 510(k) clearance on 2020-11-16. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K201918.

When was EVOS Large Fragment Plating System approved by the FDA?

EVOS Large Fragment Plating System received FDA 510(k) clearance on 2020-11-16, under approval number K201918.

What company makes EVOS Large Fragment Plating System?

EVOS Large Fragment Plating System is manufactured by Smith & Nephew, Inc..

What is the FDA product code for EVOS Large Fragment Plating System?

The FDA product code for EVOS Large Fragment Plating System is HRS.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING NCT06249776 Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial COMPLETED NCT07431723 Creation of Compression Anastomosis Using the GT Metabolic Magnet System RECRUITING NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING

Other Devices by Smith & Nephew, Inc.

K163086VLP MINI-MOD 2.0mm Column Plates K161233OXINIUM DH Fermoral Heads K161264TRIGEN Low Profile Bone Screws K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device K162078EVOS Small Fragment Plating System K160923REDAPT Anteverted Cemented Liner

View all 107 devices →

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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.

↑