Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM Threaded and Smooth Pegs, Model(S
FDA 510(k) K090374 · DePuy Orthopaedics, Inc.
510(k) numberK090374
Submission
- Device name
- Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM Threaded and Smooth Pegs, Model(S
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- February 17, 2009
- Decision date
- March 11, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K112345 | Distal Volar Radius Plating SystemsLXT · Traditional | Medos International SARL | 10/31/2011SE |
| K073135 | Synthes (USA) Hybrid External Fixator ModificationsLXT · Traditional | Synthes (Usa) | 01/29/2008SE |
| K063832 | Synthes (USA) Elbow Hinge FixatorLXT · Traditional | Synthes (Usa) | 03/07/2007SE |
| K060864 | Multidirectional Threaded PegLXT · Special | Hand Innovations, LLC | 04/28/2006SE |
| K060403 | Pta (Progressive Tibial Alignment)LXT · Traditional | Meridian Medical | 03/28/2006SE |
| K060290 | Shoulder Fixation SystemLXT · Special | Hand Innovations, LLC | 02/27/2006SE |
| K052754 | Wrist Fusion PlateLXT · Traditional | Dvo Extremity Solutions, LLC | 10/27/2005SE |
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Questions and answers
When was Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM Threaded and Smooth Pegs, Model(S cleared by the FDA?
Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM Threaded and Smooth Pegs, Model(S (K090374) received a 510(k) decision of Substantially Equivalent on March 11, 2009, 22 days after the submission was received.
What is the product code of K090374?
The FDA product code is LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite, a Class II (moderate risk) device regulated under 21 CFR 888.3030.