Free Flex Heel Height Adjustor
FDA 510(k) K823396 · Orthopedic Systems, Inc.
510(k) numberK823396
Submission
- Device name
- Free Flex Heel Height Adjustor
- Applicant
- Orthopedic Systems, Inc.
Mchenry, IL, US - Received
- November 12, 1982
- Decision date
- November 29, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ISH – Component, External, Limb, Ankle/Foot
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3420
- Specialty
- Physical Medicine
Other 510(k)s with product code ISH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051256 | Silverseal Orthotic Component with X-StaticISH · Traditional | Noble Fiber Technologies, Inc. | 07/21/2005SE |
| K820505 | Ankle/Foot ExternalISH · Traditional | Mauch Laboratories, Inc. | 03/08/1982SE |
| K791331 | The Tucker-Sach Foot and Tucker-Syme FTISH · Traditional | Kiswood Manufacturing, Inc. | 08/03/1979SE |
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| 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 Free Flex Heel Height Adjustor cleared by the FDA?
Free Flex Heel Height Adjustor (K823396) received a 510(k) decision of Substantially Equivalent on November 29, 1982, 17 days after the submission was received.
What is the product code of K823396?
The FDA product code is ISH – Component, External, Limb, Ankle/Foot, a Class I (low risk) device regulated under 21 CFR 890.3420.