FDA.report

510(k) K192660

Device
Zimmer M/L Taper Hip Prosthesis
Applicant
Zimmer, Inc.
510(k) number
K192660
Product code
LZO  
Decision
Substantially Equivalent (SESE)
Decision date
2020-02-28
Date received
2019-09-25
Regulation
888.3353
Classification name
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Caleb Barylski
Address
1800 W. Center St. Warsaw IN US 46580 46580

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00889024132283NAZimmer, Inc.2016-07-20
00889024132269NAZimmer, Inc.2016-07-20
00889024132245NAZimmer, Inc.2016-07-20
00889024132221NAZimmer, Inc.2016-07-20
00889024132207NAZimmer, Inc.2016-07-20
00889024132184NAZimmer, Inc.2016-07-20
00889024132160NAZimmer, Inc.2016-07-20
00889024132146NAZimmer, Inc.2016-07-20
00889024132122NAZimmer, Inc.2016-07-20
00889024132108NAZimmer, Inc.2016-07-20
00889024132085NAZimmer, Inc.2016-07-20
00889024132061NAZimmer, Inc.2016-07-20
00889024132047NAZimmer, Inc.2016-07-20
00889024132023NAZimmer, Inc.2016-07-20

Legacy Summary

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FDA Review

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