PEAK FX™LC CAP 814235100

GUDID 00887868037917

Biomet Orthopedics, LLC

Hip internal fixation system

• Primary Device ID: 00887868037917
• NIH Device Record Key: f750c8be-0a88-46d6-a580-8aa89b7876dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEAK FX™LC CAP
• Version Model Number: 8142-35-100
• Catalog Number: 814235100
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868037917 [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: true
• Device Is Sterile: false

[00887868037917]

Moist Heat or Steam Sterilization

[00887868037917]

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 [PEAK FX™LC CAP]

• 00887868037948: 8142-35-120
• 00887868037931: 8142-35-115
• 00887868037924: 8142-35-105
• 00887868037917: 8142-35-100
• 00887868037900: 8142-35-020
• 00887868037894: 8142-35-015
• 00887868037887: 8142-35-010
• 00887868037870: 8142-35-005
• 00887868037863: 8142-35-000