Patella 3044-0028

GUDID 07613327033793

Circular - All Polyethylene

Howmedica Osteonics Corp.

Polyethylene patella prosthesis

• Primary Device ID: 07613327033793
• NIH Device Record Key: 16a4afd5-93f1-4788-887d-0d6b726d82c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patella
• Version Model Number: 3044-0028
• Catalog Number: 3044-0028
• 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

• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter
• Outer Diameter: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327033793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K863668

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/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 [Patella]

• 07613327033823: Circular - All Polyethylene
• 07613327033809: Circular - All Polyethylene
• 07613327033793: Circular - All Polyethylene
• 07613327033779: Circular - All Polyethylene