Transfx Angled Rods
FDA 510(k) K003205 · Immedica, Inc.
510(k) numberK003205
Submission
- Device name
- Transfx Angled Rods
- Applicant
- Immedica, Inc.
Chatham, NJ, US - Received
- October 13, 2000
- Decision date
- December 15, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
| K230067 | Para-Fix External Fixation SystemLXT · Traditional | New Paradigm Biomedical | 09/22/2023SE |
| K131636 | Polarus ConnectLXT · Traditional | Acumed, LLC | 10/10/2013SE |
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| K112345 | Distal Volar Radius Plating SystemsLXT · Traditional | Medos International SARL | 10/31/2011SE |
| K090374 | Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…LXT · Special | DePuy Orthopaedics, Inc. | 03/11/2009SE |
| 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 |
More from Hand Innovations, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K023575 | Concert CranioplastGXP · Traditional | 01/22/2003SE |
| K013755 | Concert Radiopaque Bone CementLOD · Traditional | 02/08/2002SE |
| K001228 | External Fixation Anchor PinJDW · Traditional | 07/07/2000SE |
| K001084 | Trans FX Adjustable Pin to Bar ClampLXT · Traditional | 06/15/2000SE |
| K991723 | Transfx Multi Pin ClampLXT · Traditional | 07/22/1999SE |
| K990848 | Transfx Intermediate External Fixation System,Transfx Small External Fixation System…LXT · Traditional | 05/17/1999SE |
| K984357 | Transfx External Fixation SystemLXT · Traditional | 03/04/1999SE |
Questions and answers
When was Transfx Angled Rods cleared by the FDA?
Transfx Angled Rods (K003205) received a 510(k) decision of Substantially Equivalent on December 15, 2000, 63 days after the submission was received.
What is the product code of K003205?
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.