3.5 MM 90 Cannulated Limited Contact Angeled Blade Plates (3.5MM 90 Cannulated Lc-Abp)
FDA 510(k) K992837 · Synthes (Usa)
510(k) numberK992837
Submission
- Device name
- 3.5 MM 90 Cannulated Limited Contact Angeled Blade Plates (3.5MM 90 Cannulated Lc-Abp)
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- August 23, 1999
- Decision date
- October 25, 1999
- 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
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| 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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| 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 |
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Questions and answers
When was 3.5 MM 90 Cannulated Limited Contact Angeled Blade Plates (3.5MM 90 Cannulated Lc-Abp) cleared by the FDA?
3.5 MM 90 Cannulated Limited Contact Angeled Blade Plates (3.5MM 90 Cannulated Lc-Abp) (K992837) received a 510(k) decision of Substantially Equivalent on October 25, 1999, 63 days after the submission was received.
What is the product code of K992837?
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.