Trident X3 Insert 743-00-28E

GUDID 07613327341997

Trident X3 Elevated Rim Insert

Howmedica Osteonics Corp.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 07613327341997
• NIH Device Record Key: fcdfba12-5438-4995-949f-2bf5d3e2baa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trident X3 Insert
• Version Model Number: 743-00-28E
• Catalog Number: 743-00-28E
• 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

• Lumen/Inner Diameter: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327341997 [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 [Trident X3 Insert]

• 07613327342994: Trident X3 Elevated Rim Insert
• 07613327342963: Trident X3 Elevated Rim Insert
• 07613327342956: Trident X3 Elevated Rim Insert
• 07613327342857: Trident X3 Elevated Rim Insert
• 07613327342826: Trident X3 Elevated Rim Insert
• 07613327342765: Trident X3 Elevated Rim Insert
• 07613327342659: Trident X3 Elevated Rim Insert
• 07613327342628: Trident X3 Elevated Rim Insert
• 07613327342505: Trident X3 Elevated Rim Insert
• 07613327342406: Trident X3 Elevated Rim Insert
• 07613327342178: Trident X3 Elevated Rim Insert
• 07613327341997: Trident X3 Elevated Rim Insert
• 07613327341744: Trident X3 Elevated Rim Insert
• 07613327341614: Trident X3 Elevated Rim Insert
• 07613327341584: Trident X3 Elevated Rim Insert
• 07613327341492: Trident X3 Elevated Rim Insert
• 07613327341478: Trident X3 Elevated Rim Insert
• 07613327341461: Trident X3 Elevated Rim Insert
• 07613327341430: Trident X3 Elevated Rim Insert
• 07613327341416: Trident X3 Elevated Rim Insert
• 07613327339697: Trident X3 10 Degree Eccentric Insert
• 07613327339666: Trident X3 10 Degree Eccentric Insert
• 07613327339635: Trident X3 10 Degree Eccentric Insert
• 07613327339543: Trident X3 10 Degree Eccentric Insert
• 07613327339444: Trident X3 10 Degree Eccentric Insert
• 07613327339437: Trident X3 10 Degree Eccentric Insert
• 07613327339390: Trident X3 10 Degree Eccentric Insert
• 07613327339314: Trident X3 10 Degree Eccentric Insert
• 07613327339260: Trident X3 10 Degree Eccentric Insert
• 07613327339222: Trident X3 10 Degree Eccentric Insert
• 07613327339123: Trident X3 10 Degree Eccentric Insert
• 07613327339086: Trident X3 10 Degree Eccentric Insert
• 07613327339062: Trident X3 10 Degree Eccentric Insert
• 07613327339048: Trident X3 10 Degree Eccentric Insert
• 07613327339000: Trident X3 10 Degree Eccentric Insert
• 07613327338997: Trident X3 10 Degree Eccentric Insert
• 07613327338928: Trident X3 10 Degree Eccentric Insert
• 07613327338898: Trident X3 10 Degree Eccentric Insert
• 07613327338867: Trident X3 10 Degree Eccentric Insert
• 07613327338843: Trident X3 10 Degree Eccentric Insert
• 07613327338799: Trident X3 10 Degree Eccentric Insert