Sagittal & Rotary Act/Pass Knee Ligament Tester
FDA 510(k) K861622 · Orthopedic Systems, Inc.
510(k) numberK861622
Submission
- Device name
- Sagittal & Rotary Act/Pass Knee Ligament Tester
- Applicant
- Orthopedic Systems, Inc.
Hayward, CA, US - Received
- April 29, 1986
- Decision date
- May 27, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKK – System, Isokinetic Testing And Evaluation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1925
- Specialty
- Physical Medicine
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|---|---|---|---|
| K123746 | Ames Therapy DeviceIKK · Traditional | Ames Technology, Inc. | 05/24/2013SE |
| K952090 | Humac SystemIKK · Traditional | Computer Sports Medicine, Inc. | 12/11/1995SE |
| K951770 | Biodex System 3 Model S3S-AP and Model S3D-3APIKK · Traditional | Biodex Medical Systems, Inc. | 11/16/1995SE |
| K951916 | CC Rider, Model ME180IKK · Traditional | Mettler Electronics Corp. | 10/04/1995SE |
| K950095 | Cybex 770IKK · Traditional | Cybex | 06/21/1995SE |
| K942229 | Motivator FTR 2000IKK · Traditional | Hogan & Hartson | 02/27/1995SE |
| K944732 | Dexter IsokineticIKK · Traditional | Cedaron Medical, Inc. | 02/03/1995SE |
| K924414 | The Bte Dynamic LiftIKK · Traditional | Baltimore Therapeutic Equipment Co. | 02/12/1993SE |
| K923350 | Closed Chain Attachment, Model #820-520IKK · Traditional | Biodan Medical Systems, Ltd. | 07/23/1992SE |
| K922772 | Two Position Roll-Up Back Attachment ChairIKK · Traditional | Biodan Medical Systems, Ltd. | 07/13/1992SE |
More from Biodan Medical Systems, Ltd.
| 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 Sagittal & Rotary Act/Pass Knee Ligament Tester cleared by the FDA?
Sagittal & Rotary Act/Pass Knee Ligament Tester (K861622) received a 510(k) decision of Substantially Equivalent on May 27, 1986, 28 days after the submission was received.
What is the product code of K861622?
The FDA product code is IKK – System, Isokinetic Testing And Evaluation, a Class II (moderate risk) device regulated under 21 CFR 890.1925.