Warsaw Orthopedic I Bone Plate
FDA 510(k) K870727 · Warsaw Orthopedic, Inc.
510(k) numberK870727
Submission
- Device name
- Warsaw Orthopedic I Bone Plate
- Applicant
- Warsaw Orthopedic, Inc.
Warsaw, IN, US - Received
- February 24, 1987
- Decision date
- March 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
| 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 |
| K023360 | Leforte System Bone PlateKTW · Traditional | Jeil Medical Corporation | 10/25/2002SE |
| K012645 | Reprocessed Ebi External Fixation DevicesKTW · Traditional | Alliance Medical Corp. | 06/24/2002SE |
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|---|---|---|
| K892877 | Cradle, Hospital Bed ClothingFNJ · Traditional | 06/15/1989SE |
| K883784 | TSRH Anterior Spinal Screws, Staples and End PlateLYQ · Traditional | 04/06/1989SN |
| K883783 | TSRH Sacral Spinal ScrewKWP · Traditional | 04/06/1989SN |
| K880212 | TSRH H/M Hook Holder W/Rod MoverKWP · Traditional | 03/04/1988SE |
| K880211 | TSRH H/M Hook HolderKWP · Traditional | 03/04/1988SE |
| K880215 | TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal RodKWP · Traditional | 02/18/1988SE |
| K880214 | TSRH H/M Torque Limiting WrenchKWP · Traditional | 02/18/1988SE |
| K870843 | Schultz Phalangeal Comp Trial/Metacarpal Comp TriaHWT · Traditional | 05/27/1987SE |
| K870842 | Schultz Phalangeal Comp Rasp/Metacarpal Comp RaspHTP · Traditional | 05/27/1987SE |
| K870830 | Warsaw Orthopedic TSR Cross Link SystemKWP · Traditional | 05/04/1987SE |
Questions and answers
When was Warsaw Orthopedic I Bone Plate cleared by the FDA?
Warsaw Orthopedic I Bone Plate (K870727) received a 510(k) decision of Substantially Equivalent on March 9, 1987, 13 days after the submission was received.
What is the product code of K870727?
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.