Isostation Knee Machine (K-100)
FDA 510(k) K854621 · Isotechnologies, Inc.
510(k) numberK854621
Submission
- Device name
- Isostation Knee Machine (K-100)
- Applicant
- Isotechnologies, Inc.
Hillsborough, NC, US - Received
- November 18, 1985
- Decision date
- March 7, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Isotechnologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K933063 | Isotechnologies Back Tracker and Back Works SoftwaKQX · Traditional | 01/27/1994SE |
| K912175 | Isotechnologies Liftstation & Liftworks SoftwareINK · Traditional | 06/07/1991SE |
| K844060 | Isostation Ankle/Subtalar Machine A-100IKK · Traditional | 11/23/1984SE |
| K842296 | Isostation Lower Back MachineIKK · Traditional | 06/22/1984SE |
| K841849 | Isostation Shoulder MachineIKK · Traditional | 05/14/1984SE |
Questions and answers
When was Isostation Knee Machine (K-100) cleared by the FDA?
Isostation Knee Machine (K-100) (K854621) received a 510(k) decision of Substantially Equivalent on March 7, 1986, 109 days after the submission was received.