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

NKB 2019-01-15

Whistler Modular Pedicle Screw System

Applicant Evolution Spine, LLC

K-Number K182478

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GEI 2019-01-15

OsteoCool RF Ablation System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K182497

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PGY 2019-01-15

JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor

Applicant Nanjing Jusha Display Technology Co., Ltd.

K-Number K183497

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OVD 2019-01-15

Avenue P Cage System

Applicant Zimmer Biomet Spine, Inc.

K-Number K181096

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MBI 2019-01-14

TenoTac Soft Tissue Fixation System

Applicant Paragon 28, Inc.

K-Number K182898

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OOK 2019-01-14

ZELTIQ CoolSculpting System

Applicant Zeltiq Aesthetics, Inc.

K-Number K183514

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FRO 2019-01-14

Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)

Applicant Argentum Medical, LLC

K-Number K180570

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HSB 2019-01-14

Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System

Applicant Paragon 28, Inc.

K-Number K182307

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KWT 2019-01-11

Catalyst CSR Press-Fit Humeral Components

Applicant Catalyst Orthoscience, Inc.

K-Number K182500

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CCK 2019-01-11

MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly

Applicant Medipines Corporation

K-Number K180902

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NQP 2019-01-11

CD Horizon Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K182928

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OBO 2019-01-11

RESCAN 700, CALLISTO eye

Applicant Carl Zeiss Meditec, AG

K-Number K180229

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