510(k) K151440

Klassic HD Hip System by Total Joint Orthopedics, Inc. — Product Code LPH

K151440 is an FDA 510(k) premarket notification submitted by Total Joint Orthopedics, Inc. for the device "Klassic HD Hip System". The FDA issued a decision of Substantially Equivalent on September 3, 2015. 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. Total Joint Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2015
Date Received
May 29, 2015
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