Restoration ADM/MDM X3 Insert 7236-2-864

GUDID 07613327315998

Restoration ADM/MDM X3 Insert

Howmedica Osteonics Corp.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 07613327315998
• NIH Device Record Key: d903ae85-84d4-4f63-8a90-3c7039963140
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restoration ADM/MDM X3 Insert
• Version Model Number: 7236-2-864
• Catalog Number: 7236-2-864
• 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: 58 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327315998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182468

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

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/MDM X3 Insert]

• 07613327315998: Restoration ADM/MDM X3 Insert
• 07613327315974: Restoration ADM/MDM X3 Insert
• 07613327315967: Restoration ADM/MDM X3 Insert
• 07613327315851: Restoration ADM/MDM X3 Insert
• 07613327315820: Restoration ADM/MDM X3 Insert
• 07613327315813: Restoration ADM/MDM X3 Insert