XtraFix® 00-5200-090-07

GUDID 00889024080409

Zimmer, Inc.

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 00889024080409
• NIH Device Record Key: 515d61ef-4b46-4335-80f4-56e02b0b03db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XtraFix®
• Version Model Number: 00-5200-090-07
• Catalog Number: 00-5200-090-07
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024080409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141697

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

[00889024080409]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-22
• Device Publish Date: 2017-09-27

On-Brand Devices [XtraFix®]

• 00889024578760: 00-5203-020-50
• 00889024578753: 00-5203-020-38
• 00889024578746: 00-5203-020-21
• 00889024578739: 00-5203-020-18
• 00889024578722: 00-5202-020-50
• 00889024578715: 00-5202-020-38
• 00889024578708: 00-5202-020-21
• 00889024578692: 00-5202-010-18
• 00889024080577: 00-5203-006-07
• 00889024080553: 00-5202-090-30
• 00889024080546: 00-5202-090-00
• 00889024080508: 00-5202-011-60
• 00889024080492: 00-5202-011-50
• 00889024080485: 00-5202-011-40
• 00889024080478: 00-5202-011-35
• 00889024080461: 00-5202-011-30
• 00889024080454: 00-5202-011-25
• 00889024080447: 00-5202-011-20
• 00889024080430: 00-5202-011-15
• 00889024080423: 00-5202-011-10
• 00889024080409: 00-5200-090-07
• 00889024080393: 00-5200-050-04
• 00889024080386: 00-5200-040-08
• 00889024080379: 00-5200-040-04
• 00889024080362: 00-5200-030-06
• 00889024080355: 00-5200-030-04
• 00889024080348: 00-5200-020-04
• 00889024080331: 00-5200-010-07
• 00889024080324: 00-5200-010-06
• 00889024080317: 00-5200-010-05
• 00889024080300: 00-5200-010-04
• 00889024080294: 00-5200-010-03
• 00889024080287: 00-5200-010-02
• 00889024080270: 00-5200-010-01
• 00889024081475: 00-5214-040-25
• 00889024081468: 00-5214-040-20
• 00889024081451: 00-5214-030-25
• 00889024081444: 00-5214-030-20
• 00889024081437: 00-5214-025-25
• 00889024081420: 00-5214-025-20
• 00889024081413: 00-5210-095-50
• 00889024081406: 00-5210-095-00
• 00889024081390: 00-5210-090-03
• 00889024081376: 00-5210-085-00
• 00889024081352: 00-5210-075-50
• 00889024081345: 00-5210-075-10
• 00889024081338: 00-5210-075-01
• 00889024081321: 00-5210-075-00
• 00889024081307: 00-5210-050-06
• 00889024081291: 00-5210-050-05