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 2020-10-06

NuVasive® Cohere® Thoracolumbar Interbody System

Applicant Nu Vasive, Incorporated

K-Number K200953

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MBL 2020-10-06

R3 HA Coated Acetabular Shells

Applicant Smith & Nephew, Inc.

K-Number K201701

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GEI 2020-10-06

CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20

Applicant Bolder Surgical, LLC

K-Number K202114

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LBI 2020-10-05

Neonatal Phototherapy System

Applicant Avalon Biomedical (Shenzhen) Limited

K-Number K200031

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PQC 2020-10-05

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides

Applicant Medacta Inernational SA

K-Number K200792

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IZH 2020-10-05

Affirm Contrast Biopsy

Applicant Hologic, Inc.

K-Number K202294

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NKB 2020-10-05

KHEIRON® Spinal Fixation System

Applicant S.M.A.I.O

K-Number K201659

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DZL 2020-10-05

Membrane Screws and Membrane Tacks

Applicant Neoss Limited

K-Number K201561

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PKL 2020-10-05

ClearEndoclip

Applicant Finemedix Co., Ltd.

K-Number K200217

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LLZ 2020-10-05

UDE

Applicant Ebm Technologies, Inc.

K-Number K202292

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HSX 2020-10-02

Materialise PKA Guide System

Applicant Materialise NV

K-Number K202207

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QEW 2020-10-02

ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device

Applicant Boston Scientific Corporation

K-Number K202218

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