FDA.report

510(k) K200151

Device
Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter
Applicant
Zimmer, Inc.
510(k) number
K200151
Product code
HSX  
Decision
Substantially Equivalent (SESE)
Decision date
2020-03-17
Date received
2020-01-22
Regulation
888.3520
Classification name
Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
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
Pankti Shah
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
00889024582873Persona®Zimmer, Inc.2020-03-25
00889024582866Persona®Zimmer, Inc.2020-03-25
00889024582859Persona®Zimmer, Inc.2020-03-25
00889024582842Persona®Zimmer, Inc.2020-03-25
00880304809116Persona®Biomet Orthopedics, LLC2016-12-13
00880304809109Persona®Biomet Orthopedics, LLC2016-12-13
00880304809093Persona®Biomet Orthopedics, LLC2016-12-13
00880304809086Persona®Biomet Orthopedics, LLC2016-12-13
00889024192683N/AZimmer, Inc.2016-05-24

Legacy Summary

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FDA Review

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