Lamoreux-Osi Electrogoniometer
FDA 510(k) K831040 · Orthopedic Systems, Inc.
510(k) numberK831040
Submission
- Device name
- Lamoreux-Osi Electrogoniometer
- Applicant
- Orthopedic Systems, Inc.
Mchenry, IL, US - Received
- March 31, 1983
- Decision date
- July 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQX – Goniometer, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.1500
- Specialty
- Orthopedic
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| K925225 | The Bte Vector; Analysis System for the Low BackKQX · Traditional | Baltimore Therapeutic Equipment Co. | 06/27/1994SE |
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| 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 Lamoreux-Osi Electrogoniometer cleared by the FDA?
Lamoreux-Osi Electrogoniometer (K831040) received a 510(k) decision of Substantially Equivalent on July 12, 1983, 103 days after the submission was received.
What is the product code of K831040?
The FDA product code is KQX – Goniometer, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 888.1500.