510(k) K130099

TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 by Encore Medical L.P. — Product Code LPH

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)

Source: FDA 510(k) database entry for K130099. Report a data issue: hello@regdatalab.com.