Tritanium 509-22-66

GUDID 07613327025675

Non-Modular Shell

Howmedica Osteonics Corp.

Acetabular shell

• Primary Device ID: 07613327025675
• NIH Device Record Key: ee73352b-173b-4b2a-bc72-0756c58a13f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tritanium
• Version Model Number: 509-22-66
• Catalog Number: 509-22-66
• 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

• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter
• Outer Diameter: 66 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327025675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090897

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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 [Tritanium]

• 07613327040210: Hemispherical Cluster Hole Shell
• 07613327040197: Hemispherical Cluster Hole Shell
• 07613327040180: Hemispherical Cluster Hole Shell
• 07613327040173: Hemispherical Cluster Hole Shell
• 07613327040166: Hemispherical Cluster Hole Shell
• 07613327040159: Hemispherical Cluster Hole Shell
• 07613327040142: Hemispherical Cluster Hole Shell
• 07613327040135: Hemispherical Cluster Hole Shell
• 07613327040128: Hemispherical Cluster Hole Shell
• 07613327040111: Hemispherical Cluster Hole Shell
• 07613327040104: Hemispherical Cluster Hole Shell
• 07613327040098: Hemispherical Cluster Hole Shell
• 07613327040081: Hemispherical Solid Back Shell
• 07613327040074: Hemispherical Solid Back Shell
• 07613327040067: Hemispherical Solid Back Shell
• 07613327040050: Hemispherical Solid Back Shell
• 07613327040043: Hemispherical Solid Back Shell
• 07613327040036: Hemispherical Solid Back Shell
• 07613327040029: Hemispherical Solid Back Shell
• 07613327040012: Hemispherical Solid Back Shell
• 07613327040005: Hemispherical Solid Back Shell
• 07613327039993: Hemispherical Solid Back Shell
• 07613327039986: Hemispherical Solid Back Shell
• 07613327039979: Hemispherical Solid Back Shell
• 07613327025736: Non-Modular Shell
• 07613327025712: Non-Modular Shell
• 07613327025705: Non-Modular Shell
• 07613327025699: Non-Modular Shell
• 07613327025682: Non-Modular Shell
• 07613327025675: Non-Modular Shell
• 07613327025668: Non-Modular Shell
• 07613327025651: Non-Modular Shell
• 07613327025644: Non-Modular Shell
• 07613327025620: Non-Modular Shell