LOW PROFILE CORTICAL SCREW 131218050

GUDID 00887868012761

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868012761
• NIH Device Record Key: 6586ad22-2339-486e-8805-f14ec02bb74c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOW PROFILE CORTICAL SCREW
• Version Model Number: 1312-18-050
• Catalog Number: 131218050
• 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
• 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 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	00887868012761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082300

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

Moist Heat or Steam Sterilization

[00887868012761]

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 [LOW PROFILE CORTICAL SCREW]

• 00887868012761: 1312-18-050
• 00887868012860: 1312-18-099
• 00887868012853: 1312-18-095
• 00887868012846: 1312-18-090
• 00887868012839: 1312-18-085
• 00887868012822: 1312-18-080
• 00887868012815: 1312-18-075
• 00887868012808: 1312-18-070
• 00887868012792: 1312-18-065
• 00887868012785: 1312-18-060
• 00887868012778: 1312-18-055
• 00887868012754: 1312-18-048
• 00887868012747: 1312-18-046
• 00887868012730: 1312-18-044
• 00887868012723: 1312-18-042
• 00887868012716: 1312-18-040
• 00887868012709: 1312-18-038
• 00887868012693: 1312-18-036
• 00887868012686: 1312-18-034
• 00887868012679: 1312-18-032
• 00887868012662: 1312-18-030
• 00887868012655: 1312-18-028
• 00887868012648: 1312-18-026
• 00887868012631: 1312-18-024
• 00887868012624: 1312-18-022
• 00887868012617: 1312-18-020
• 00887868012600: 1312-18-018
• 00887868012594: 1312-18-016
• 00887868012587: 1312-18-014
• 00887868012570: 1312-18-012
• 00887868012563: 1312-18-010
• 00887868549700: 1312-18-099
• 00887868549694: 1312-18-095
• 00887868549687: 1312-18-090
• 00887868549670: 1312-18-085
• 00887868549663: 1312-18-080
• 00887868549656: 1312-18-075
• 00887868549625: 1312-18-060
• 00887868549601: 1312-18-050
• 00887868549595: 1312-18-048
• 00887868549588: 1312-18-046
• 00887868549571: 1312-18-044
• 00887868549564: 1312-18-042
• 00887868549557: 1312-18-040
• 00887868549540: 1312-18-038
• 00887868549533: 1312-18-036
• 00887868549526: 1312-18-034
• 00887868549519: 1312-18-032
• 00887868549502: 1312-18-030
• 00887868549496: 1312-18-028