510(k) K131237

PIPELINE TOTAL HIP SYSTEM by Pipeline Orthopedics — Product Code LPH

K131237 is an FDA 510(k) premarket notification submitted by Pipeline Orthopedics for the device "PIPELINE TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on June 13, 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. Pipeline Orthopedics has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2013
Date Received
May 1, 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