Ankle-Foot Cast/Splint
FDA 510(k) K811690 · Surgical Appliance Industries, Inc.
510(k) numberK811690
Submission
- Device name
- Ankle-Foot Cast/Splint
- Applicant
- Surgical Appliance Industries, Inc.
Mchenry, IL, US - Received
- June 15, 1981
- Decision date
- June 25, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IQI – Orthosis, Limb Brace
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Specialty
- Physical Medicine
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| K143458 | NeurosplintIQI · Traditional | Neurospectrum, LLC | 08/13/2015SE |
| K052771 | Sensor WalkIQI · Traditional | Otto Bock Healthcare LP | 05/03/2006SE |
| K031576 | Spartan Orthopaedic Wrist Brace, Model SCT-1IQI · Traditional | Surgitech, Inc. | 07/31/2003SE |
| K926391 | Accuflex Dynamic Elbow OrthosisIQI · Traditional | Regulatory & Marketing Services, Inc. | 07/22/1993SE |
| K910974 | Mcconnell Shoulder BraceIQI · Traditional | Mcconnell Orthopedic | 03/21/1991SE |
| K874502 | Gait-Aid Orthopedic InsoleIQI · Traditional | Gait-Aid, Inc. | 11/30/1987SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | Fred Sammons, Inc. | 06/24/1983SE |
| K831615 | Drop Foot BraceIQI · Traditional | Edward Dilauro, Jr. | 06/15/1983SE |
| K823812 | Various Supports and SplintsIQI · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823113 | Brace-Up All Purpose Wrist BandIQI · Traditional | Arco Matic, Inc. | 11/16/1982SE |
More from Arco Matic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K121106 | Truform Ready-To-Wear Compression Arm Sleece Truform Ready-To-Wear Compression GauntletDWL · Traditional | 04/27/2012SE |
| K821682 | Truncal OrthosisIQE · Traditional | 06/24/1982SE |
| K813416 | External Breast ProsthesisGBI · Traditional | 01/18/1982SE |
| K812423 | Neoprene Knee SupportITQ · Traditional | 09/14/1981SE |
| K812422 | Custom Contour Lumbosacral OrthosisIPY · Traditional | 09/14/1981SE |
| K812401 | Cruciform Anterior Spinal Hyperexten. OIPT · Traditional | 09/14/1981SE |
| K811689 | Cylinder Knee Cast/SplintITQ · Traditional | 06/25/1981SE |
| K811494 | Lumbo-Sacral Flexion OrthosisIPY · Traditional | 06/16/1981SE |
Questions and answers
When was Ankle-Foot Cast/Splint cleared by the FDA?
Ankle-Foot Cast/Splint (K811690) received a 510(k) decision of Substantially Equivalent on June 25, 1981, 10 days after the submission was received.
What is the product code of K811690?
The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.