510(k) K032824
K032824 is an FDA 510(k) premarket notification submitted by Stelkast Company for the device "STELKAST UNICONDYLAR KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 13, 2003. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Stelkast Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2003
- Date Received
- September 10, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3520
- Review Panel
- OR
- Submission Type