Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Sc…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200043

Identifiers

510(k) Number: K200043 FDA 510(k)
FDA Product Code: HRS FDA 510(k)
Models / Variants: Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws FDA 510(k)
Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 888.3030 FDA 510(k)
Regulation Number: 888.3030 FDA 510(k)
Advisory Committee: Orthopedic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Sc… by Field Orthopaedics Pty Ltd — Class II — FDA_510K — listed in FDA 510(k)…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K200043	Class II	Active

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Manufacturer

Manufacturer: Field Orthopaedics Pty Ltd
FDA Applicant: Field Orthopaedics Pty, Ltd.

Sources (1)

FDA 510(k) K200043 24 fields · synced Jun 18, 2026