Traction-Steel Framing System
FDA 510(k) K823395 · Orthopedic Systems, Inc.
510(k) numberK823395
Submission
- Device name
- Traction-Steel Framing System
- 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
- HST – Apparatus, Traction, Non-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.5850
- Specialty
- Orthopedic
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| K872121 | K and D Home TractHST · Traditional | Joseph A. Kott, M.D. | 08/12/1987SE |
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| K870125 | Extremity ElevatorHST · Traditional | Orthopedic Systems, Inc. | 02/04/1987SE |
| K870102 | Tupper TrolleyHST · Traditional | Orthopedic Systems, Inc. | 02/03/1987SE |
| K864765 | Model 668, Traction Splint, AdultHST · Traditional | Ferno-Washington, Inc. | 12/17/1986SE |
| K862874 | The Towered 90/90 UnitHST · Traditional | Lossing Orthopedic, Inc. | 08/07/1986SE |
| K860037 | Suspender Orthopedic Suspension DeviceHST · Traditional | Comfortex, Inc. | 01/21/1986SE |
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| 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 Traction-Steel Framing System cleared by the FDA?
Traction-Steel Framing System (K823395) 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 K823395?
The FDA product code is HST – Apparatus, Traction, Non-Powered, a Class I (low risk) device regulated under 21 CFR 888.5850.