Series I 3051-0308

GUDID 07613327033922

Tibial Bearing Insert

Howmedica Osteonics Corp.

Tibial insert

• Primary Device ID: 07613327033922
• NIH Device Record Key: 5a900c3a-caf1-432b-abdb-7d3be5f3202c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Series I
• Version Model Number: 3051-0308
• Catalog Number: 3051-0308
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327033922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862837

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

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: 2015-09-24

On-Brand Devices [Series I]

• 07613327033939: Tibial Bearing Insert
• 07613327033922: Tibial Bearing Insert