Comus Locking Plate systems

FDA 510(k) Premarket Notification · Submission K190842 · Applicant: Jiangsu Trauhui Medical Instrument Co., Ltd.

Public Record 510(k) Submission Decision Date: 2020-02-03 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K190842.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K190842
Device Name
Comus Locking Plate systems
Product Code
HRS
Decision Date
2020-02-03
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
Orthopedic (OR)
Clearance Type
Traditional
Third Party Flag
N
Date Received
2019-04-01

Related Establishments / Registrations

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