NEXGEN®

GUDID 00889024310544

ZIMMER TRABECULAR METAL TECHNOLOGY INC.

Trabeculated knee tibia/insert prosthesis

• Primary Device ID: 00889024310544
• NIH Device Record Key: 948ab16b-893d-4630-93eb-cdab9df7c60e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEXGEN®
• Version Model Number: 00-5886-064-14
• Company DUNS: 793120965
• Company Name: ZIMMER TRABECULAR METAL TECHNOLOGY 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• 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

• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Height: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024310544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020295

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-17

On-Brand Devices [NEXGEN®]

• 00889024465688: 00-5879-067-29
• 00889024465671: 00-5879-065-29
• 00889024310827: 00-5987-092-02
• 00889024310810: 00-5887-056-00
• 00889024310803: 00-5887-055-00
• 00889024310797: 00-5887-052-00
• 00889024310780: 00-5887-051-00
• 00889024310773: 00-5887-048-00
• 00889024310766: 00-5887-047-00
• 00889024310759: 00-5887-046-00
• 00889024310742: 00-5887-045-00
• 00889024310735: 00-5887-044-00
• 00889024310728: 00-5887-043-00
• 00889024310711: 00-5886-075-17
• 00889024310704: 00-5886-075-14
• 00889024310698: 00-5886-075-12
• 00889024310681: 00-5886-075-10
• 00889024310674: 00-5886-067-17
• 00889024310667: 00-5886-067-14
• 00889024310650: 00-5886-067-12
• 00889024310643: 00-5886-067-10
• 00889024310636: 00-5886-066-17
• 00889024310629: 00-5886-066-14
• 00889024310612: 00-5886-066-12
• 00889024310605: 00-5886-066-10
• 00889024310599: 00-5886-065-17
• 00889024310582: 00-5886-065-14
• 00889024310575: 00-5886-065-12
• 00889024310568: 00-5886-065-10
• 00889024310551: 00-5886-064-17
• 00889024310544: 00-5886-064-14
• 00889024310537: 00-5886-064-12
• 00889024310520: 00-5886-064-10
• 00889024310513: 00-5886-063-17
• 00889024310506: 00-5886-063-14
• 00889024310490: 00-5886-063-12
• 00889024310483: 00-5886-063-10
• 00889024310476: 00-5886-058-17
• 00889024310469: 00-5886-058-14
• 00889024310452: 00-5886-058-12
• 00889024310445: 00-5886-058-10
• 00889024310438: 00-5886-057-17
• 00889024310421: 00-5886-057-14
• 00889024310414: 00-5886-057-12
• 00889024310407: 00-5886-057-10
• 00889024310391: 00-5886-056-17
• 00889024310384: 00-5886-056-14
• 00889024310377: 00-5886-056-12
• 00889024310360: 00-5886-056-10
• 00889024310353: 00-5886-055-17