510(k) K072888

REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED) by Encore Medical L.P. — Product Code LPH

K072888 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)". The FDA issued a decision of Substantially Equivalent on Jan 10, 2008. 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
Jan 10, 2008
Date Received
Oct 10, 2007
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 K072888. Report a data issue: hello@regdatalab.com.