Synthes Reconstructive Plates 'Y' Plates
FDA 510(k) K792291 · Synthes (Usa)
510(k) numberK792291
Submission
- Device name
- Synthes Reconstructive Plates 'Y' Plates
- Applicant
- Synthes (Usa)
Walker, MI, US - Received
- November 13, 1979
- Decision date
- December 6, 1979
- 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 |
|---|---|---|
| K180821 | TruMatch Graft Cage - Long BoneHRS · Traditional | 12/21/2018SE |
| K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction SystemKTT · Traditional | 11/10/2016SE |
| K152239 | Zero-P Natural Plate SystemKWQ · Traditional | 12/02/2015SE |
| K141527 | Depuy Synthes Variable Angle Locking Hand SystemHRS · Traditional | 03/30/2015SE |
| K131984 | Synthes Synsonic Ulna NailHSB · Traditional | 03/31/2014SE |
| K130146 | Synthes Synflate Vertevral Balloon SystemNDN · Traditional | 05/20/2013SE |
| K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateHRS · Traditional | 07/06/2012SE |
| K112030 | Synthes Radial Head Prosthesis SystemKWI · Traditional | 06/19/2012SE |
| K120854 | Synthes Va LCP Ankle Trauma SystemHRS · Traditional | 06/18/2012SE |
| K120275 | Synthes Acis/Vertebral Spacer CRODP · Traditional | 05/25/2012SE |
Questions and answers
When was Synthes Reconstructive Plates 'Y' Plates cleared by the FDA?
Synthes Reconstructive Plates 'Y' Plates (K792291) received a 510(k) decision of Substantially Equivalent on December 6, 1979, 23 days after the submission was received.
What is the product code of K792291?
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.