Natural-Knee®

GUDID 00889024255463

Zimmer, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00889024255463
• NIH Device Record Key: f89e6e38-ba82-47de-87f9-0c40faae5236
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natural-Knee®
• Version Model Number: 6245-01-711
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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@zimmer.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
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024255463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002335

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

[00889024255463]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-05-24

On-Brand Devices [Natural-Knee®]

• 00889024259416: 6420-00-285
• 00889024259409: 6420-00-280
• 00889024259324: 6415-08-215
• 00889024259287: 6415-08-211
• 00889024259256: 6415-08-015
• 00889024259249: 6415-08-014
• 00889024259232: 6415-08-013
• 00889024259218: 6415-08-011
• 00889024259195: 6415-08-000
• 00889024259188: 6415-04-215
• 00889024259140: 6415-04-211
• 00889024259133: 6415-04-210
• 00889024259119: 6415-04-015
• 00889024259096: 6415-04-013
• 00889024259089: 6415-04-012
• 00889024259072: 6415-04-011
• 00889024259065: 6415-04-010
• 00889024259058: 6415-04-000
• 00889024252370: 6215-10-002
• 00889024252363: 6215-10-001
• 00889024251472: 6208-00-214
• 00889024251465: 6208-00-213
• 00889024251441: 6208-00-211
• 00889024251427: 6208-00-204
• 00889024251403: 6208-00-202
• 00889024251380: 6208-00-200
• 00889024251366: 6208-00-113
• 00889024251359: 6208-00-112
• 00889024251342: 6208-00-111
• 00889024251335: 6208-00-110
• 00889024251328: 6208-00-104
• 00889024251281: 6208-00-100
• 00889024251274: 6208-00-010
• 00889024251250: 6207-12-213
• 00889024251229: 6207-12-210
• 00889024251205: 6207-12-203
• 00889024251199: 6207-12-202
• 00889024251168: 6207-12-114
• 00889024251090: 6207-12-102
• 00889024251052: 6207-08-310
• 00889024251045: 6207-08-304
• 00889024251038: 6207-08-303
• 00889024251021: 6207-08-302
• 00889024251014: 6207-08-301
• 00889024251007: 6207-08-300
• 00889024250994: 6207-08-214
• 00889024250987: 6207-08-213
• 00889024250970: 6207-08-212
• 00889024250963: 6207-08-211
• 00889024250956: 6207-08-210