SOLID CANCELLOUS BONE SCREW 14369115

GUDID 00887868010361

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868010361
• NIH Device Record Key: 2372cb7e-cd70-44f0-a06a-ebd080a372ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLID CANCELLOUS BONE SCREW
• Version Model Number: 14369-115
• Catalog Number: 14369115
• 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: true
• 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
• 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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868010361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K882831

FDA Product Code

• HRS: Plate, fixation, bone
• HWC: Screw, fixation, bone

Sterilization

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

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

[00887868010361]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [SOLID CANCELLOUS BONE SCREW]

• 00887868010361: 14369-115
• 00887868010354: 14369-110
• 00887868010347: 14369-105
• 00887868008177: 14369-95
• 00887868008160: 14369-90
• 00887868008153: 14369-85
• 00887868008146: 14369-80
• 00887868008139: 14369-75
• 00887868008122: 14369-70
• 00887868008115: 14369-65
• 00887868008108: 14369-60
• 00887868008092: 14369-55
• 00887868008085: 14369-50
• 00887868008078: 14369-48
• 00887868008061: 14369-46
• 00887868008054: 14369-44
• 00887868008047: 14369-42
• 00887868008030: 14369-40
• 00887868008023: 14369-38
• 00887868008016: 14369-36
• 00887868008009: 14369-34
• 00887868007996: 14369-32
• 00887868007989: 14369-30
• 00887868007972: 14369-28
• 00887868007965: 14369-26
• 00887868007958: 14369-24
• 00887868007941: 14369-22
• 00887868007934: 14369-20
• 00887868007927: 14369-18
• 00887868007910: 14369-16
• 00887868007903: 14369-14
• 00887868007897: 14369-12