Leforte System Bone Plate
FDA 510(k) K023360 · Jeil Medical Corporation
510(k) numberK023360
Submission
- Device name
- Leforte System Bone Plate
- Applicant
- Jeil Medical Corporation
Deer Field, IL, US - Received
- October 7, 2002
- Decision date
- October 25, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTW – Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KTW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182285 | PK High Tibial Osteotomy Correction SystemKTW · Traditional | Paonan Biotech Co., Ltd. | 06/20/2019SE |
| K171606 | AOS Anterolateral Proximal Humeral PlateKTW · Special | Advanced Orthopaedic Solutions, Inc. (Aos) | 06/22/2017SE |
| K170693 | Phantom Small Bone Intramedullary Nail SystemKTW · Traditional | Paragon 28, Inc. | 06/19/2017SE |
| K160409 | AOS Anterolateral Proximal Humeral PlateKTW · Special | Advanced Orthopaedic Solutions, Inc. | 03/15/2016SE |
| K122541 | Orthofix Contours Proimal Humeral Plate (PHP)KTW · Special | Orthofix Srl | 09/20/2012SE |
| K080590 | Aos Proximal Humeral PlateKTW · Traditional | Advanced Orthopaedic Solutions, Inc. | 05/06/2008SE |
| K080109 | Synthes (USA) Modular Blade Plate SystemKTW · Traditional | Synthes (Usa) | 03/20/2008SE |
| K062920 | Orthofix Titanium Humeral Plating System LSPKTW · Traditional | Orthofix Srl | 11/13/2006SE |
| K012645 | Reprocessed Ebi External Fixation DevicesKTW · Traditional | Alliance Medical Corp. | 06/24/2002SE |
| K012634 | Reprocessed External Fixation DeviceKTW · Traditional | Alliance Medical, Inc. | 06/24/2002SE |
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| K252246 | Leforte MMF SystemJEY · Traditional | 04/02/2026SE |
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| K251431 | FIX-C PEEK ACIF SA SystemOVE · Traditional | 06/27/2025SE |
| K243973 | FIX-L PEEK PLIF and T-PLIF SystemMAX · Traditional | 06/12/2025SE |
| K242751 | ARIX Pectus Bar SystemHRS · Traditional | 05/30/2025SE |
| K242247 | ARIX Femur Nail SystemHSB · Traditional | 04/22/2025SE |
| K243915 | FIX-C 3D Ti ACIF SystemODP · Traditional | 02/18/2025SE |
| K243004 | Xpine Spinal Fixation SystemNKB · Traditional | 11/08/2024SE |
| K231251 | FlexWing Anterior Cervical Plate SystemKWQ · Traditional | 07/24/2024SE |
| K233912 | ARIX Cannulated Screw SystemHWC · Traditional | 03/11/2024SE |
Questions and answers
When was Leforte System Bone Plate cleared by the FDA?
Leforte System Bone Plate (K023360) received a 510(k) decision of Substantially Equivalent on October 25, 2002, 18 days after the submission was received.
What is the product code of K023360?
The FDA product code is KTW – Appliance, Fixation, Nail/Blade/Plate Combination, Single Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.