510(k) K132959

DEPUY PINNACLE ALTRX ACETABULAR LINERS by DePuy Orthopaedics, Inc. — Product Code LPH

K132959 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "DEPUY PINNACLE ALTRX ACETABULAR LINERS". The FDA issued a decision of Substantially Equivalent on March 10, 2014. 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. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2014
Date Received
September 20, 2013
Clearance Type
Traditional
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