NexGen LCCK Knee System 82-0156-869-05

GUDID 00889024478602

Zimmer, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00889024478602
• NIH Device Record Key: 0df5872b-7376-4198-aee5-3505069fb9e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexGen LCCK Knee System
• Version Model Number: 82-0156-869-05
• Catalog Number: 82-0156-869-05
• 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: true
• Lot Batch: false
• Serial Number: true
• 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)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024478602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152494

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[00889024478602]

Moist Heat or Steam Sterilization

[00889024478602]

Moist Heat or Steam Sterilization

[00889024478602]

Moist Heat or Steam Sterilization

[00889024478602]

Moist Heat or Steam Sterilization

[00889024478602]

Moist Heat or Steam Sterilization

[00889024478602]

Moist Heat or Steam Sterilization

[00889024478602]

Moist Heat or Steam Sterilization

[00889024478602]

Moist Heat or Steam Sterilization

[00889024478602]

Moist Heat or Steam Sterilization

[00889024478602]

Moist Heat or Steam Sterilization

[00889024478602]

Moist Heat or Steam Sterilization

[00889024478602]

Moist Heat or Steam Sterilization

[00889024478602]

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: 2016-11-14

On-Brand Devices [NexGen LCCK Knee System]

• 00889024478664: 82-0156-869-11
• 00889024478657: 82-0156-869-10
• 00889024478640: 82-0156-869-09
• 00889024478633: 82-0156-869-08
• 00889024478626: 82-0156-869-07
• 00889024478619: 82-0156-869-06
• 00889024478602: 82-0156-869-05
• 00889024478596: 82-0156-869-04
• 00889024478589: 82-0156-869-03
• 00889024478572: 82-0156-869-02
• 00889024478565: 82-0156-869-01
• 00889024478558: 82-0156-869-00