BIOMET KNEE STEM EXTENSION TRIAL 32-341642

GUDID 00880304459649

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304459649
• NIH Device Record Key: 890c834a-82de-413c-a155-be6aac591898
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOMET KNEE STEM EXTENSION TRIAL
• Version Model Number: 32-341642
• Catalog Number: 32-341642
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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)348-9500
• 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
• Phone: +1(800)348-9500
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304459649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093293

FDA Product Code

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

Sterilization

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

[00880304459649]

Moist Heat or Steam Sterilization

[00880304459649]

Moist Heat or Steam Sterilization

[00880304459649]

Moist Heat or Steam Sterilization

[00880304459649]

Moist Heat or Steam Sterilization

[00880304459649]

Moist Heat or Steam Sterilization

[00880304459649]

Moist Heat or Steam Sterilization

[00880304459649]

Moist Heat or Steam Sterilization

[00880304459649]

Moist Heat or Steam Sterilization

[00880304459649]

Moist Heat or Steam Sterilization

[00880304459649]

Moist Heat or Steam Sterilization

[00880304459649]

Moist Heat or Steam Sterilization

[00880304459649]

Moist Heat or Steam Sterilization

[00880304459649]

Moist Heat or Steam Sterilization

[00880304459649]

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: 2016-09-22

On-Brand Devices [BIOMET KNEE STEM EXTENSION TRIAL]

• 00880304537002: 32-341701
• 00880304536937: 32-341699
• 00880304536920: 32-341697
• 00880304536890: 32-341657
• 00880304536876: 32-341663
• 00880304536869: 32-341659
• 00880304536852: 32-341661
• 00880304536838: 32-341641
• 00880304531895: 32-341664
• 00880304459700: 32-341702
• 00880304459694: 32-341700
• 00880304459687: 32-341698
• 00880304459670: 32-341696
• 00880304459663: 32-341694
• 00880304459656: 32-341692
• 00880304459649: 32-341642
• 00880304459588: 32-341902
• 00880304459571: 32-341900
• 00880304459564: 32-341898
• 00880304459557: 32-341896
• 00880304459540: 32-341894
• 00880304459533: 32-341892
• 00880304452817: 32-341650
• 00880304325043: 32-341882
• 00880304325036: 32-341880
• 00880304325029: 32-341878
• 00880304325012: 32-341876
• 00880304325005: 32-341874
• 00880304324992: 32-341872
• 00880304324589: 32-341662
• 00880304324572: 32-341660
• 00880304324565: 32-341658
• 00880304324558: 32-341656
• 00880304324541: 32-341652
• 00880304000421: 32-341654