OSSEOTI® RECONSTRUCTIVE WEDGE SYSTEM 597019

GUDID 00880304840805

Biomet Orthopedics, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00880304840805
• NIH Device Record Key: 77e0287e-e2c8-405b-af39-d7431db875be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSEOTI® RECONSTRUCTIVE WEDGE SYSTEM
• Version Model Number: 597019
• Catalog Number: 597019
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304840805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122770

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00880304840805]

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: 2017-05-04

Devices Manufactured by Biomet Orthopedics, LLC

• 00887868004087 - PRIMARY TREPHINE: 2024-04-03
• 00887868004094 - BUSHING: 2024-04-03
• 00887868004100 - SECONDARY TREPHINE: 2024-04-03
• 00887868048272 - TREPHINE: 2024-04-03
• 00887868048289 - TREPHINE: 2024-04-03
• 00887868048296 - TREPHINE: 2024-04-03
• 00887868048302 - TREPHINE: 2024-04-03
• 00880304658387 - Compress®: 2024-03-11