XtraFix® 00-5202-011-60

GUDID 00889024080508

Zimmer, Inc.

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00889024080508
NIH Device Record Key76034a68-44ba-4bef-8972-fcd1bb2b7460
Commercial Distribution StatusIn Commercial Distribution
Brand NameXtraFix®
Version Model Number00-5202-011-60
Catalog Number00-5202-011-60
Company DUNS056038268
Company NameZimmer, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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

Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0
Length600 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024080508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


[00889024080508]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-22
Device Publish Date2017-09-27

On-Brand Devices [XtraFix®]

0088902457876000-5203-020-50
0088902457875300-5203-020-38
0088902457874600-5203-020-21
0088902457873900-5203-020-18
0088902457872200-5202-020-50
0088902457871500-5202-020-38
0088902457870800-5202-020-21
0088902457869200-5202-010-18
0088902408057700-5203-006-07
0088902408055300-5202-090-30
0088902408054600-5202-090-00
0088902408050800-5202-011-60
0088902408049200-5202-011-50
0088902408048500-5202-011-40
0088902408047800-5202-011-35
0088902408046100-5202-011-30
0088902408045400-5202-011-25
0088902408044700-5202-011-20
0088902408043000-5202-011-15
0088902408042300-5202-011-10
0088902408040900-5200-090-07
0088902408039300-5200-050-04
0088902408038600-5200-040-08
0088902408037900-5200-040-04
0088902408036200-5200-030-06
0088902408035500-5200-030-04
0088902408034800-5200-020-04
0088902408033100-5200-010-07
0088902408032400-5200-010-06
0088902408031700-5200-010-05
0088902408030000-5200-010-04
0088902408029400-5200-010-03
0088902408028700-5200-010-02
0088902408027000-5200-010-01
0088902408147500-5214-040-25
0088902408146800-5214-040-20
0088902408145100-5214-030-25
0088902408144400-5214-030-20
0088902408143700-5214-025-25
0088902408142000-5214-025-20
0088902408141300-5210-095-50
0088902408140600-5210-095-00
0088902408139000-5210-090-03
0088902408137600-5210-085-00
0088902408135200-5210-075-50
0088902408134500-5210-075-10
0088902408133800-5210-075-01
0088902408132100-5210-075-00
0088902408130700-5210-050-06
0088902408129100-5210-050-05

Trademark Results [XtraFix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XTRAFIX
XTRAFIX
77735219 3786057 Live/Registered
ZIMMER, INC.
2009-05-12

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