A.L.P.S.PROXIMAL TIBIA LOCKED PLATE, RIGHT STANDARD 816235807

GUDID 00887868045165

Biomet Orthopedics, LLC

Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00887868045165
• NIH Device Record Key: 10fae3a8-63bf-40c0-886c-68897b0a3264
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.L.P.S.PROXIMAL TIBIA LOCKED PLATE, RIGHT STANDARD
• Version Model Number: 8162-35-807
• Catalog Number: 816235807
• 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
• 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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868045165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090877

FDA Product Code

• HTN: WASHER, BOLT NUT

Sterilization

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

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

Moist Heat or Steam Sterilization

[00887868045165]

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 [A.L.P.S.PROXIMAL TIBIA LOCKED PLATE, RIGHT STANDARD]

• 00887868045202: 8162-35-815
• 00887868045196: 8162-35-813
• 00887868045189: 8162-35-811
• 00887868045172: 8162-35-809
• 00887868045165: 8162-35-807
• 00887868045158: 8162-35-805
• 00887868045141: 8162-35-803