Walking Heel
FDA 510(k) K823394 · Orthopedic Systems, Inc.
510(k) numberK823394
Submission
- Device name
- Walking Heel
- 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
- LGF – Component, Cast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.5940
- Specialty
- Orthopedic
Other 510(k)s with product code LGF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K043526 | Silverseal Tubular Wound Dressing with X-StaticLGF · Traditional | Noble Fiber Technologies, Inc. | 03/10/2005SE |
| K973420 | Clinitex Cast PaddingLGF · Traditional | Clinitex Medical Corp. | 12/09/1997SE |
| K973417 | Clinitex StockinetteLGF · Traditional | Clinitex Medical Corp. | 12/09/1997SE |
| K955320 | Protec Cotton Padding BandageLGF · Traditional | Derivadas Degasa S.A. DE C.V. | 01/26/1996SE |
| K932507 | Quick-Cast ImmobilizerLGF · Traditional | Landec Corp. | 02/23/1994SE |
| K931672 | Carapace Sterile Cast PaddingLGF · Traditional | Carapace, Inc. | 12/15/1993SE |
| K910274 | Artiflex(Tm)LGF · Traditional | Beiersdorf, Inc. | 03/05/1991SE |
| K903946 | Cool Cast(R)LGF · Traditional | Hawthorne Products, Inc. | 12/31/1990SE |
| K896634 | Caraglas Xtra Synthetic Casting TapeLGF · Traditional | Buckman Co., Inc. | 06/14/1990SE |
| K883294 | Synthetic Cast TapeLGF · Traditional | Carapace, Inc. | 08/30/1988SE |
More from Carapace, 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 Walking Heel cleared by the FDA?
Walking Heel (K823394) 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 K823394?
The FDA product code is LGF – Component, Cast, a Class I (low risk) device regulated under 21 CFR 888.5940.