PEAK FX™LAG ASSEMBLY 814232320

GUDID 00887868037443

Biomet Orthopedics, LLC

Hip internal fixation system

• Primary Device ID: 00887868037443
• NIH Device Record Key: b00148a9-ab1f-4862-a8b3-7284286c8e34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEAK FX™LAG ASSEMBLY
• Version Model Number: 8142-32-320
• Catalog Number: 814232320
• 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	00887868037443 [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™LAG ASSEMBLY]

• 00887868037849: 8142-33-490
• 00887868037832: 8142-33-480
• 00887868037825: 8142-33-470
• 00887868037818: 8142-33-430
• 00887868037801: 8142-33-420
• 00887868037795: 8142-33-410
• 00887868037788: 8142-33-400
• 00887868037771: 8142-33-390
• 00887868037764: 8142-33-380
• 00887868037757: 8142-33-370
• 00887868037740: 8142-33-330
• 00887868037733: 8142-33-320
• 00887868037726: 8142-33-310
• 00887868037719: 8142-33-300
• 00887868037702: 8142-33-290
• 00887868037696: 8142-33-280
• 00887868037689: 8142-33-270
• 00887868037672: 8142-33-230
• 00887868037665: 8142-33-220
• 00887868037658: 8142-33-210
• 00887868037641: 8142-33-200
• 00887868037634: 8142-33-130
• 00887868037627: 8142-33-120
• 00887868037610: 8142-33-110
• 00887868037603: 8142-33-100
• 00887868037597: 8142-33-090
• 00887868037580: 8142-33-080
• 00887868037573: 8142-33-070
• 00887868037559: 8142-32-490
• 00887868037542: 8142-32-480
• 00887868037535: 8142-32-470
• 00887868037528: 8142-32-430
• 00887868037511: 8142-32-420
• 00887868037504: 8142-32-410
• 00887868037498: 8142-32-400
• 00887868037481: 8142-32-390
• 00887868037474: 8142-32-380
• 00887868037467: 8142-32-370
• 00887868037450: 8142-32-330
• 00887868037443: 8142-32-320
• 00887868037436: 8142-32-310
• 00887868037429: 8142-32-300
• 00887868037412: 8142-32-290
• 00887868037405: 8142-32-280
• 00887868037399: 8142-32-270
• 00887868037382: 8142-32-230
• 00887868037375: 8142-32-220
• 00887868037368: 8142-32-210
• 00887868037351: 8142-32-200
• 00887868037344: 8142-32-130