MDM X3 Insert 7236-2-244

GUDID 07613327315905

X3 Insert for MDM Liner

Howmedica Osteonics Corp.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 07613327315905
• NIH Device Record Key: 909db032-627d-4cba-84c1-9d3c75bdff0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MDM X3 Insert
• Version Model Number: 7236-2-244
• Catalog Number: 7236-2-244
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 38 Millimeter
• Lumen/Inner Diameter: 22.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 38 Millimeter
• Lumen/Inner Diameter: 22.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 38 Millimeter
• Lumen/Inner Diameter: 22.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 38 Millimeter
• Lumen/Inner Diameter: 22.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 38 Millimeter
• Lumen/Inner Diameter: 22.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 38 Millimeter
• Lumen/Inner Diameter: 22.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 38 Millimeter
• Lumen/Inner Diameter: 22.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 38 Millimeter
• Lumen/Inner Diameter: 22.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 38 Millimeter
• Lumen/Inner Diameter: 22.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 38 Millimeter
• Lumen/Inner Diameter: 22.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 38 Millimeter
• Lumen/Inner Diameter: 22.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 38 Millimeter
• Lumen/Inner Diameter: 22.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 38 Millimeter
• Lumen/Inner Diameter: 22.2 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 38 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327315905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182468

FDA Product Code

• KWZ: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-20
• Device Publish Date: 2019-11-12

On-Brand Devices [MDM X3 Insert]

• 07613327315905: X3 Insert for MDM Liner
• 07613327315899: X3 Insert for MDM Liner
• 07613327602708: X3 Insert for MDM Liner