510(k) K022437
K022437 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "UNI KNEE". The FDA issued a decision of Substantially Equivalent on Aug 23, 2002. The device falls under product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3530. Encore Medical L.P. has 81 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 23, 2002
- Date Received
- Jul 25, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3530
- Review Panel
- OR
- Submission Type
- 510(k)