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

OVD 2020-03-25

NuVasive 3DP Interfixated ALIF System

Applicant Nu Vasive, Incorporated

K-Number K193593

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PHX 2020-03-25

Medacta Shoulder System

Applicant Medacta International S.A.

K-Number K192967

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NKG 2020-03-25

NorthStar OCT Spinal System

Applicant SeaSpine Orthopedics Corporation

K-Number K193615

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JAK 2020-03-25

syngo.CT Cardiac Planning

Applicant Siemens Medical Soultions USA, Inc.

K-Number K200515

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OAP 2020-03-25

Shapiro MD model laser 272

Applicant Conversion Labs, Pr, LLC

K-Number K193667

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ONF 2020-03-25

IPL + Diode Laser Machine

Applicant Beijing Globalipl Development Co., Ltd.

K-Number K193328

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GEH 2020-03-25

Cry-Ac®, Cry-Ac-3®, Cry-Baby

Applicant Brymill Cryogenic Systems

K-Number K193619

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NHA 2020-03-25

MIS CONNECT Conical Connection System

Applicant Dentsply Sirona

K-Number K193078

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PBX 2020-03-25

TempSure System

Applicant Cynosure, LLC

K-Number K200241

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HRS 2020-03-25

FINE Osteotomy around the knee

Applicant Bodycad Laboratories, Inc.

K-Number K193614

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KWQ 2020-03-24

SEA-LINK Anterior Cervical Plate System

Applicant Indius Medical Technologies Pvt. , Ltd.

K-Number K200224

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NKB 2020-03-24

RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System

Applicant OrthoPediatrics Corp.

K-Number K193100

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