Trident 65C-2248

GUDID 07613327023992

Polyethylene Acetabular Cup

Howmedica Osteonics Corp.

Combination-material acetabulum prosthesis

• Primary Device ID: 07613327023992
• NIH Device Record Key: 0ef7ff44-7cd4-4e41-8507-ce7a4029fd50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trident
• Version Model Number: 65C-2248
• Catalog Number: 65C-2248
• 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

• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 48 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327023992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001956

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

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 [Trident]

• 07613327039962: 10 Degree Polyethylene Insert
• 07613327039955: 10 Degree Polyethylene Insert
• 07613327039948: 10 Degree Polyethylene Insert
• 07613327039931: 10 Degree Polyethylene Insert
• 07613327039924: 10 Degree Polyethylene Insert
• 07613327039917: 10 Degree Polyethylene Insert
• 07613327039900: 10 Degree Polyethylene Insert
• 07613327039894: 10 Degree Polyethylene Insert
• 07613327039887: 10 Degree Polyethylene Insert
• 07613327039870: 10 Degree Polyethylene Insert
• 07613327039863: 10 Degree Polyethylene Insert
• 07613327039856: 10 Degree Polyethylene Insert
• 07613327039849: 10 Degree Polyethylene Insert
• 07613327039832: 10 Degree Polyethylene Insert
• 07613327039825: 10 Degree Polyethylene Insert
• 07613327039818: 10 Degree Polyethylene Insert
• 07613327039801: 10 Degree Polyethylene Insert
• 07613327039795: 10 Degree Polyethylene Insert
• 07613327039788: 10 Degree Polyethylene Insert
• 07613327039771: 10 Degree Polyethylene Insert
• 07613327039764: 10 Degree Polyethylene Insert
• 07613327039757: 10 Degree Polyethylene Insert
• 07613327039740: 10 Degree Polyethylene Insert
• 07613327039733: 10 Degree Polyethylene Insert
• 07613327039726: 10 Degree Polyethylene Insert
• 07613327039719: 10 Degree Polyethylene Insert
• 07613327039702: 10 Degree Polyethylene Insert
• 07613327039696: 10 Degree Polyethylene Insert
• 07613327039689: 10 Degree Polyethylene Insert
• 07613327039672: 10 Degree Polyethylene Insert
• 07613327039665: 10 Degree Polyethylene Insert
• 07613327039658: 10 Degree Polyethylene Insert
• 07613327039641: 10 Degree Polyethylene Insert
• 07613327039634: 10 Degree Polyethylene Insert
• 07613327039627: 10 Degree Polyethylene Insert
• 07613327039610: 10 Degree Polyethylene Insert
• 07613327039603: 10 Degree Polyethylene Insert
• 07613327039597: 10 Degree Polyethylene Insert
• 07613327039580: 0 Degree Polyethylene Insert
• 07613327039573: 10 Degree Polyethylene Insert
• 07613327039566: 0 Degree Polyethylene Insert
• 07613327039559: 0 Degree Polyethylene Insert
• 07613327039542: 0 Degree Polyethylene Insert
• 07613327039535: 0 Degree Polyethylene Insert
• 07613327039528: 0 Degree Polyethylene Insert
• 07613327039511: 0 Degree Polyethylene Insert
• 07613327039504: 0 Degree Polyethylene Insert
• 07613327039498: 0 Degree Polyethylene Insert
• 07613327039481: 0 Degree Polyethylene Insert
• 07613327039474: 0 Degree Polyethylene Insert