ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer(r) Persona The Personalized Kee System 14x +30mm Tapered Stem Extension.

Pre-market Notification Details

• Device ID: K133737
• 510k Number: K133737
• Device Name: ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Pauline A Shand
• Correspondent: Pauline A Shand; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-09
• Decision Date: 2014-02-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024247734	K133737	000