Stax Finger Splints
FDA 510(k) K823393 · Orthopedic Systems, Inc.
510(k) numberK823393
Submission
- Device name
- Stax Finger Splints
- Applicant
- Orthopedic Systems, Inc.
Mchenry, IL, US - Received
- November 12, 1982
- Decision date
- December 3, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILH – Splint, Hand, And Components
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Specialty
- Physical Medicine
Other 510(k)s with product code ILH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K832144 | Splint WoodILH · Traditional | Vermont Wood Industries, Inc. | 08/01/1983SE |
| K831548 | SplintsILH · Traditional | Fred Sammons, Inc. | 06/27/1983SE |
| K823647 | Finger Extension SplintILH · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823644 | Finger Flexion SplintILH · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823666 | Universal Wrist Splint & Forearm SplintILH · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823601 | Wrist SupportILH · Traditional | Fred Sammons, Inc. | 12/22/1982SE |
| K823165 | Wrist Spling & Forearm SplintILH · Traditional | Warm & Form, Orthopedic Materials | 11/16/1982SE |
| K822651 | Total Finger Flexion SplintILH · Traditional | Alimed, Inc. | 09/17/1982SE |
| K821637 | Wire-Foam MP Flexion SpringILH · Traditional | Fred Sammons, Inc. | 06/11/1982SE |
| K821635 | Soft Ulnar Deviation SplintsILH · Traditional | Fred Sammons, Inc. | 06/11/1982SE |
More from Fred Sammons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | 01/22/1996SE |
| K920256 | Spine Motion Analyzer with EmgKQX · Traditional | 08/10/1992SE |
| K910736 | Jackson Multipurpose Operating TableJEA · Traditional | 05/21/1991SE |
| K910031 | Park City Shoulder PositionerFWZ · Traditional | 01/24/1991SE |
| K903938 | C Fit CupJDI · Traditional | 01/04/1991SN |
| K892503 | Nuffield Total KneeJWH · Traditional | 05/04/1990SN |
| K896678 | Silicone PlugHRX · Traditional | 01/30/1990SE |
| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | 01/19/1990SE |
| K890498 | Freeman Modular Hip Stem Ridged VersionJDI · Traditional | 10/13/1989SN |
| K890331 | Freeman Total Hip System Ridged StemLWJ · Traditional | 10/13/1989SE |
Questions and answers
When was Stax Finger Splints cleared by the FDA?
Stax Finger Splints (K823393) received a 510(k) decision of Substantially Equivalent on December 3, 1982, 21 days after the submission was received.
What is the product code of K823393?
The FDA product code is ILH – Splint, Hand, And Components, a Class I (low risk) device regulated under 21 CFR 890.3475.