Levtech Small Bone Plate
FDA 510(k) K893928 · Buckman Co., Inc.
510(k) numberK893928
Submission
- Device name
- Levtech Small Bone Plate
- Applicant
- Buckman Co., Inc.
Martinez, CA, US - Received
- May 31, 1989
- Decision date
- November 3, 1989
- 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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| K964252 | OrthochuckGEY · Traditional | 05/27/1997SE |
| K950099 | Synergy(Tm) Ti Posterior Spinal SystemMNH · Traditional | 01/16/1997SN |
| K960451 | Webb-Morley Spine SystemMNH · Traditional | 04/18/1996SN |
| K950999 | KSF Posterior Spingal Fixator for Severe SpondylolisthesisMNH · Traditional | 01/25/1996SE |
| K945756 | Imagn(Tm) 2000 SystemGKZ · Traditional | 12/19/1995SE |
| K940003 | Volumet CD4 + and CD8 + T Lymphocyte Count Test KitGKZ · Traditional | 10/19/1995SE |
| K951117 | Lihtan 532 LaserGEX · Traditional | 10/18/1995SE |
| K942751 | Vanguard Series Gas RegulatorsCAN · Traditional | 02/09/1995SE |
Questions and answers
When was Levtech Small Bone Plate cleared by the FDA?
Levtech Small Bone Plate (K893928) received a 510(k) decision of Substantially Equivalent on November 3, 1989, 156 days after the submission was received.
What is the product code of K893928?
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.