Sagittal Knee Tester
FDA 510(k) K831041 · Orthopedic Systems, Inc.
510(k) numberK831041
Submission
- Device name
- Sagittal Knee Tester
- Applicant
- Orthopedic Systems, Inc.
Mchenry, IL, US - Received
- March 31, 1983
- Decision date
- June 24, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTY – Tape, Measuring, Rulers And Calipers
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| 510(k) | Device | Decision |
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| 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 Sagittal Knee Tester cleared by the FDA?
Sagittal Knee Tester (K831041) received a 510(k) decision of Substantially Equivalent on June 24, 1983, 85 days after the submission was received.
What is the product code of K831041?
The FDA product code is FTY – Tape, Measuring, Rulers And Calipers, a Class I (low risk) device regulated under 21 CFR 878.4800.