Restoration ADM X3 Insert 7236-2-862

GUDID 07613327316025

Restoration ADM X3 Insert

Howmedica Osteonics Corp.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 07613327316025
• NIH Device Record Key: f85951ef-5e13-408f-bf20-d7c0a2dd8cfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restoration ADM X3 Insert
• Version Model Number: 7236-2-862
• Catalog Number: 7236-2-862
• 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: 56 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 56 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 56 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 56 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 56 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 56 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 56 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 56 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 56 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 56 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 56 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 56 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 56 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 56 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327316025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182468

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

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 [Restoration ADM X3 Insert]

• 07613327316032: Restoration ADM X3 Insert
• 07613327316025: Restoration ADM X3 Insert
• 07613327316018: Restoration ADM X3 Insert
• 07613327315950: Restoration ADM X3 Insert