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

MAX 2017-06-27

Tranquil Interbody System

Applicant Nexus Spine, LLC

K-Number K170297

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HRS 2017-06-27

Distal Elbow Plating System

Applicant Skeletal Dynamics, LLC

K-Number K171590

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HWC 2017-06-27

Cannulated Screws Neoortho

Applicant Neoortho Produtos Ortopedicos S/A

K-Number K162874

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BSP 2017-06-27

Pinpoint GT Needles

Applicant C.R. Bard, Inc.

K-Number K163216

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LYZ 2017-06-27

Powder-Free Clear Vinyl Patient Examination Gloves

Applicant Zibo Yue Fan Medical Products Co, Ltd.

K-Number K170735

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LPH 2017-06-26

PROCOTYL® PRIME Acetabular Cup System

Applicant Microport Orthopedics, Inc.

K-Number K170444

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OKP 2017-06-26

SpringTMS

Applicant Eneura, Inc.

K-Number K162797

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MAX 2017-06-26

NuVasive® CoRoent® Thoracolumbar System

Applicant Nu Vasive, Incorporated

K-Number K170962

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NHI 2017-06-26

Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit

Applicant Spr Therapeutics, LLC

K-Number K170902

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DPS 2017-06-26

CardioLogs ECG Analysis Platform

Applicant Cardiologs Technologies

K-Number K170568

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NKB 2017-06-26

Swedge Pedicle Screw Fixation System

Applicant Spinal Resources, Inc.

K-Number K170045

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DJR 2017-06-26

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators

Applicant Lin-Zhi International, Inc.

K-Number K170416

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