NexGen Knee System 82-0152-982-27

GUDID 00889024473010

Zimmer, Inc.

Knee femur prosthesis trial
Primary Device ID00889024473010
NIH Device Record Keya05d1052-9b12-41b9-8083-a0463b0af5ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexGen Knee System
Version Model Number82-0152-982-27
Catalog Number82-0152-982-27
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)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone1(800)348-9500
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
GS100889024473010 [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

[00889024473010]

Moist Heat or Steam Sterilization


[00889024473010]

Moist Heat or Steam Sterilization


[00889024473010]

Moist Heat or Steam Sterilization


[00889024473010]

Moist Heat or Steam Sterilization


[00889024473010]

Moist Heat or Steam Sterilization


[00889024473010]

Moist Heat or Steam Sterilization


[00889024473010]

Moist Heat or Steam Sterilization


[00889024473010]

Moist Heat or Steam Sterilization


[00889024473010]

Moist Heat or Steam Sterilization


[00889024473010]

Moist Heat or Steam Sterilization


[00889024473010]

Moist Heat or Steam Sterilization


[00889024473010]

Moist Heat or Steam Sterilization


[00889024473010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-12-22

On-Brand Devices [NexGen Knee System]

0088902447301082-0152-982-27
0088902447300382-0152-982-26
0088902447299082-0152-982-25
0088902447298382-0152-982-24
0088902447297682-0152-982-23
0088902447296982-0152-982-22
0088902447295282-0152-982-21
0088902447294582-0152-982-17
0088902447293882-0152-982-16
0088902447292182-0152-982-15
0088902447291482-0152-982-14
0088902447290782-0152-982-13
0088902447289182-0152-982-12
0088902447288482-0152-982-11
0088902447287782-0152-907-30

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