510(k) K130099
K130099 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019". The FDA issued a decision of Substantially Equivalent on Jun 21, 2013. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Encore Medical L.P. has 81 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 21, 2013
- Date Received
- Jan 15, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3358
- Review Panel
- OR
- Submission Type
- 510(k)