Bone Screws
FDA 510(k) K843554 · Mecron Medical Products, Inc.
510(k) numberK843554
Submission
- Device name
- Bone Screws
- Applicant
- Mecron Medical Products, Inc.
Walker, MI, US - Received
- September 10, 1984
- Decision date
- October 1, 1984
- 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
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 |
| 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 |
More from Alliance Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K861138 | Mash DermatomeGFD · Traditional | 04/14/1986SE |
| K854191 | Mecron Uncemented Structured Stem Hip · Traditional | 11/13/1985SE |
| K844775 | Effner-Eye Cautery with Battery HandleHQO · Traditional | 08/12/1985SE |
| K844774 | Effner Fiber Optic Cables for Cold Light TransmissFCR · Traditional | 04/22/1985SE |
| K844488 | Mecron Cemented Structured Stem Hip ProsthesisKWL · Traditional | 03/12/1985SE |
| K844487 | Mecron Femoral Head W/Cone AS Unipolar or BipolarKWL · Traditional | 02/19/1985SE |
| K844486 | Mecron Mrc-Headless Femoral ComponentKWL · Traditional | 02/19/1985SE |
| K844773 | Eff-Effner BulbsFFS · Traditional | 01/08/1985SE |
| K843449 | Autodynamic Compression Hip Screw-PlateKTT · Traditional | 10/22/1984SE |
| K843553 | Bone PlatesKTW · Traditional | 10/01/1984SE |
Questions and answers
When was Bone Screws cleared by the FDA?
Bone Screws (K843554) received a 510(k) decision of Substantially Equivalent on October 1, 1984, 21 days after the submission was received.
What is the product code of K843554?
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.