510(k) K082398
K082398 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS". The FDA issued a decision of Substantially Equivalent on Oct 15, 2008. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Encore Medical L.P. has 81 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 15, 2008
- Date Received
- Aug 20, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type
- 510(k)