510(k) K183129

Medtronic Total Hip Arthroplasty System by Medtronic Advanced Energy — Product Code LPH

K183129 is an FDA 510(k) premarket notification submitted by Medtronic Advanced Energy for the device "Medtronic Total Hip Arthroplasty System". The FDA issued a decision of Substantially Equivalent on July 26, 2019. 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. Medtronic Advanced Energy has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2019
Date Received
November 13, 2018
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