510(k) K182678

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling by Zimmer, Inc. — Product Code LPH

K182678 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling". The FDA issued a decision of Substantially Equivalent on May 31, 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. Zimmer, Inc. has 421 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2019
Date Received
Sep 26, 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
510(k)