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

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

ODP 2017-06-20

Summit Spine Channel Cervical Interbody Fusion System

Applicant Summit Spine

K-Number K163494

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HTY 2017-06-20

Stryker SonicPin System

Applicant Stryker Trauma GmbH

K-Number K170418

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NGX 2017-06-20

Compex Sport Elite

Applicant Djo, LLC

K-Number K170918

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HRS 2017-06-20

Additive Orthopaedics Bunion System

Applicant Additive Orthopaedics, LLC

K-Number K163593

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MSV 2017-06-19

ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA

Applicant Immco Diagnostics, Inc.

K-Number K162788

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KTW 2017-06-19

Phantom Small Bone Intramedullary Nail System

Applicant Paragon 28, Inc.

K-Number K170693

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KWZ 2017-06-19

Smith & Nephew, Inc. R3™ Constrained Liner

Applicant Smith & Nephew, Inc.

K-Number K162641

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KWS 2017-06-19

Materialise Glenoid Positioning System

Applicant Materialise NV

K-Number K170893

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NGX 2017-06-19

Compex Wireless USA

Applicant Djo, LLC

K-Number K170903

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MAX 2017-06-19

Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System

Applicant Vertera, Inc.

K-Number K163506

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GEX 2017-06-19

DEKA MOTUS AX

Applicant El.En Electronic Engineering Spa

K-Number K162886

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LFD 2017-06-19

Hydris™ Oral Rinse

Applicant Biopharm Consult, LLC

K-Number K163029

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