PEAK FX™PLATE 814230010

GUDID 00887868037153

Biomet Orthopedics, LLC

Hip internal fixation system

• Primary Device ID: 00887868037153
• NIH Device Record Key: 8447ac8a-36b8-4dfa-85df-9adb124291d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEAK FX™PLATE
• Version Model Number: 8142-30-010
• Catalog Number: 814230010
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868037153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063509

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

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 [PEAK FX™PLATE]

• 00887868037221: 8142-30-112
• 00887868037214: 8142-30-110
• 00887868037207: 8142-30-108
• 00887868037191: 8142-30-106
• 00887868037184: 8142-30-104
• 00887868037177: 8142-30-102
• 00887868037160: 8142-30-012
• 00887868037153: 8142-30-010
• 00887868037146: 8142-30-008
• 00887868037139: 8142-30-006
• 00887868037122: 8142-30-004
• 00887868037115: 8142-30-003
• 00887868037108: 8142-30-002