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

LPH 2017-06-08

UTF Stem, reduced, #0, #00

Applicant United Orthopedic Corporation

K-Number K163193

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GAM 2017-06-08

Novosyn Quick Absorbable Suture

Applicant Aesculap, Inc.

K-Number K170661

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FTM 2017-06-08

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend

Applicant Acell, Inc.

K-Number K170763

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IYE 2017-06-08

Accuray Precision Treatment Planning System

Applicant Accuray Incorporated

K-Number K171086

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EHD 2017-06-08

Intraskan DC Plus

Applicant Skanray Technologies Private Limited

K-Number K170967

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NKB 2017-06-08

ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System

Applicant Choicespine, LP

K-Number K170821

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HTN 2017-06-08

INVISIKNOT Ankle Syndesmosis Repair Kit

Applicant Smith & Nephew, Inc.

K-Number K162996

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EBZ 2017-06-08

Valiant Curing Light

Applicant Inter-Med/Vista Dental Products

K-Number K170101

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KWQ 2017-06-08

Trifore(tm) Cervical Plating System

Applicant Neurostructures, Inc.

K-Number K171112

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LRK 2017-06-08

ASD Oral Appliances

Applicant American Sleep Dentistry

K-Number K163580

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DXJ 2017-06-08

Sorin Connect

Applicant Sorin Group Deutschland GmbH

K-Number K170460

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OVE 2017-06-08

NuVasive CoRoent Small Interlock II System

Applicant Nu Vasive, Incorporated

K-Number K170961

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