510(k) K023794
K023794 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "CONSTRAINED LINER". The FDA issued a decision of Substantially Equivalent on Apr 1, 2003. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. Encore Medical L.P. has 81 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 1, 2003
- Date Received
- Nov 13, 2002
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3310
- Review Panel
- OR
- Submission Type
- 510(k)