Zimmer Persona Knee System SSI004298

GUDID 00889024504417

Zimmer, Inc.

Knee tibia prosthesis trial
Primary Device ID00889024504417
NIH Device Record Key1002ce05-c285-4f6c-b112-7ac7404708f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameZimmer Persona Knee System
Version Model NumberSSI004298
Catalog NumberSSI004298
Company DUNS056038268
Company NameZimmer, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024504417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024504417]

Moist Heat or Steam Sterilization


[00889024504417]

Moist Heat or Steam Sterilization


[00889024504417]

Moist Heat or Steam Sterilization


[00889024504417]

Moist Heat or Steam Sterilization


[00889024504417]

Moist Heat or Steam Sterilization


[00889024504417]

Moist Heat or Steam Sterilization


[00889024504417]

Moist Heat or Steam Sterilization


[00889024504417]

Moist Heat or Steam Sterilization


[00889024504417]

Moist Heat or Steam Sterilization


[00889024504417]

Moist Heat or Steam Sterilization


[00889024504417]

Moist Heat or Steam Sterilization


[00889024504417]

Moist Heat or Steam Sterilization


[00889024504417]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2018-03-26

On-Brand Devices [Zimmer Persona Knee System]

00889024508569SSI004272
00889024508552SSI004271
00889024508545SSI004270
00889024508538SSI004269
00889024508521SSI004268
00889024508514SSI004267
00889024508507SSI004266
00889024508491SSI004265
00889024508484SSI004264
00889024508477SSI004263
0088902450845382-0153-150-00
00889024506947SSI004335
00889024506930SSI004335
00889024506923SSI004334
00889024506916SSI004333
00889024506909SSI004332
00889024506893SSI004331
00889024506886SSI004330
00889024506879SSI004329
00889024506862SSI004328
00889024506855SSI004327
00889024506848SSI004192
00889024506831SSI004191
00889024506824SSI004189
00889024504462SSI004303
00889024504455SSI004302
00889024504448SSI004301
00889024504431SSI004300
00889024504424SSI004299
00889024504417SSI004298
00889024504400SSI004297
00889024504394SSI004296
00889024504387SSI004295
00889024504370SSI004294
00889024504363SSI004293
00889024504356SSI004292
00889024504349SSI004291
00889024504332SSI004290
0088902447350882-0156-872-04
0088902447349282-0156-872-05
0088902447348582-0156-872-06
0088902447347882-0156-872-07
0088902447346182-0156-872-14
0088902447345482-0156-872-15
0088902447344782-0156-872-16
0088902447343082-0156-872-17
0088902447143682-0153-184-20
0088902447142982-0153-184-00

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.