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) Clearances

510(k) cleared devices tracked by MedTracker

HWC 2017-06-20

Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw

Applicant Tyber Medical, LLC

K-Number K170571

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PEM 2017-06-20

Premium Plus Disposable Barrier Sleeve

Applicant Premium Plus International Limited

K-Number K163447

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LZO 2017-06-20

Corin MetaFix Hip Stem

Applicant Corin U.S.A. Limited

K-Number K162942

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FRC 2017-06-20

STERRAD VELOCITY Biological Indictator and Reader

Applicant Advanced Sterilization Products (Asp)

K-Number K170039

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BZC 2017-06-20

COSMED K5 Wearable Metabolic Technology

Applicant Cosmed Srl

K-Number K162515

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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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