TM TIBIA W/SPIKES SSI005568

GUDID 00889024584259

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024584259
• NIH Device Record Key: dacee1cf-1684-484d-8dae-9a862aa1466f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TM TIBIA W/SPIKES
• Version Model Number: SSI005568
• Catalog Number: SSI005568
• 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: 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) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@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 Identifiers

Device Issuing Agency	Device ID
GS1	00889024584259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173417

FDA Product Code

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

Sterilization

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

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

[00889024584259]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-20
• Device Publish Date: 2020-02-12

On-Brand Devices [TM TIBIA W/SPIKES]

• 00889024584273: SSI005570
• 00889024584266: SSI005569
• 00889024584259: SSI005568
• 00889024584242: SSI005567
• 00889024584235: SSI005566
• 00889024584228: SSI005565
• 00889024584211: SSI005564
• 00889024584204: SSI005563
• 00889024584198: SSI005562
• 00889024584181: SSI005561
• 00889024584174: SSI005560
• 00889024584167: SSI005559
• 00889024584150: SSI005558
• 00889024584143: SSI005557