The Icr Knee
FDA 510(k) K820719 · American Ortomed Corp.
510(k) numberK820719
Submission
- Device name
- The Icr Knee
- Applicant
- American Ortomed Corp.
Mchenry, IL, US - Received
- March 16, 1982
- Decision date
- May 12, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from American Ortomed Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K842518 | Uniloc-Cementless & Self Tap AcetabularKWA · Traditional | 01/30/1985SE |
| K842466 | Titanium Mittelmeier Type AcetabularKWA · Traditional | 01/30/1985SE |
| K842465 | UnilocKWL · Traditional | 11/19/1984SE |
| K840413 | Cement RestrictorJDK · Traditional | 03/05/1984SE |
| K780497 | Spheristem Total Hip ProsthesisJDG · Traditional | 06/14/1978SE |
Questions and answers
When was The Icr Knee cleared by the FDA?
The Icr Knee (K820719) received a 510(k) decision of Substantially Equivalent on May 12, 1982, 57 days after the submission was received.