Various Supports and Splints
FDA 510(k) K823812 · Danek Medical, Inc.
510(k) numberK823812
Submission
- Device name
- Various Supports and Splints
- Applicant
- Danek Medical, Inc.
Mchenry, IL, US - Received
- December 17, 1982
- Decision date
- January 14, 1983
- 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 |
| K823113 | Brace-Up All Purpose Wrist BandIQI · Traditional | Arco Matic, Inc. | 11/16/1982SE |
| K823160 | Rotation BootIQI · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
More from Warm & Form, Orthopedic Materials
| 510(k) | Device | Decision |
|---|---|---|
| K994122 | Bone Graft Washer, Model 9090114 - 9090118KWQ · Traditional | 02/18/2000SE |
| K993810 | CD Horizon Spinal SystemMNH · Special | 02/03/2000SE |
| K993855 | Atlantis Anterior Cervical Plate SystemKWQ · Special | 12/15/1999SE |
| K991528 | Modification to Tenor Spinal System-Rod/Bolt ConnectorMNH · Special | 05/28/1999SE |
| K990603 | Modification of the Zplate-Atl Anterior Fixation SystemKWQ · Special | 03/10/1999SE |
| K982875 | Modification to Zplate-Atl Anterior Fixation SystemKWQ · Special | 01/19/1999SE |
| K984522 | Modification of TSRH Spinal SystemMNI · Special | 01/06/1999SE |
| K982154 | Modification of Townley Pedicle Screw Plating SystemMNI · Special | 07/13/1998SE |
| K970599 | Townley Pedicle Screw Plating SystemMNI · Traditional | 03/20/1998SE |
| K943827 | Spine FixationMNH · Traditional | 02/14/1996SN |
Questions and answers
When was Various Supports and Splints cleared by the FDA?
Various Supports and Splints (K823812) received a 510(k) decision of Substantially Equivalent on January 14, 1983, 28 days after the submission was received.
What is the product code of K823812?
The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.