True/Lok Monolateral/Bilateral Fixator
FDA 510(k) K941048 · Applied Osteo Systems, Inc.
510(k) numberK941048
Submission
- Device name
- True/Lok Monolateral/Bilateral Fixator
- Applicant
- Applied Osteo Systems, Inc.
Walnut Creek, CA, US - Received
- March 7, 1994
- Decision date
- October 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
|---|---|---|
| K935383 | Femrod and Femrod Recon InsertHSB · Traditional | 03/21/1995SE |
| K933995 | True/Flextm Femur Rods, Caps, Screws and InstrumentationHSB · Traditional | 01/27/1995SE |
| K944501 | True/Flex Intramedullary Rod End-CapHSB · Traditional | 11/28/1994SE |
| K943160 | Interference ScrewHWC · Traditional | 09/30/1994SN |
| K934148 | True/Flex Clavicle RodsHSB · Traditional | 02/22/1994SE |
| K932853 | Pin Holders, Transfixing Pins, Ol Wires, Half PinsJEL · Traditional | 02/22/1994SE |
| K931578 | Texas Scottish Rite Easy/Lock FixatorJEC · Traditional | 02/22/1994SE |
| K926465 | Femoral Intramedullary RodsJDS · Traditional | 08/25/1993SE |
| K924657 | True/Flex Metatarsal RodsKTW · Traditional | 11/24/1992SE |
| K924656 | True/ Flex Fibula RodsHSB · Traditional | 11/24/1992SE |
Questions and answers
When was True/Lok Monolateral/Bilateral Fixator cleared by the FDA?
True/Lok Monolateral/Bilateral Fixator (K941048) received a 510(k) decision of Substantially Equivalent on October 3, 1994, 210 days after the submission was received.
What is the product code of K941048?
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.