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FDA 510(k)

Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range

K-Number: K200043 · 2020-03-23

ApplicantField Orthopaedics Pty, Ltd.
Decision Date2020-03-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range is a medical device manufactured by Field Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2020-03-23 under approval number K200043. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range?

Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range is a medical device that received FDA 510(k) clearance on 2020-03-23. It is manufactured by Field Orthopaedics Pty, Ltd.. The 510(k) number is K200043.

When was Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range approved by the FDA?

Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range received FDA 510(k) clearance on 2020-03-23, under approval number K200043.

What company makes Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range?

Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range is manufactured by Field Orthopaedics Pty, Ltd..

What is the FDA product code for Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range?

The FDA product code for Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range is HRS.

Related Clinical Trials

NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING

Related PubMed Literature

PMID: 39993988 [Analysis of Brain-Computer Interface Technology in the Medical Field and the Regulation of the US FDA]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Field Orthopaedics Pty, Ltd.

K180348Field Orthopaedics Micro Screw System K230118Bony Trauma Extremity System (BTES) Screw Range, NX Nail

Related Devices (Code: HRS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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