TITAN 3-D Wedge System P03-905-9001

GUDID 00889795020024

TITAN, Evans Wedge Inserter

PARAGON 28, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00889795020024
• NIH Device Record Key: 952e098e-f6fe-4c43-9365-b1e6ed624d0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TITAN 3-D Wedge System
• Version Model Number: P03-905-9001
• Catalog Number: P03-905-9001
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00889795020024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162241

FDA Product Code

• PLF: Bone Wedge

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

[00889795020024]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-23
• Device Publish Date: 2020-12-15

On-Brand Devices [TITAN 3-D Wedge System]

• 00889795020062: TITAN, Cotton Resection Guide - Odd Sizes
• 00889795020055: TITAN, Cotton Resection Guide - Even Sizes
• 00889795020048: TITAN, Evans Resection Guide
• 00889795018236: TITAN 3-D Wedge, Cotton, 8mm, Sterile
• 00889795018229: TITAN 3-D Wedge, Cotton, 7mm, Sterile
• 00889795018212: TITAN 3-D Wedge, Cotton, 6mm, Sterile
• 00889795018205: TITAN 3-D Wedge, Cotton, 5mm, Sterile
• 00889795018199: TITAN 3-D Wedge, Evans, Large, 12mm, Sterile
• 00889795018182: TITAN 3-D Wedge, Evans, Large, 10mm, Sterile
• 00889795018175: TITAN 3-D Wedge, Evans, Large, 8mm, Sterile
• 00889795018168: TITAN 3-D Wedge, Evans, Large, 6mm, Sterile
• 00889795018151: TITAN 3-D Wedge, Evans, Small, 12mm, Sterile
• 00889795018144: TITAN 3-D Wedge, Evans, Small, 10mm, Sterile
• 00889795018137: TITAN 3-D Wedge, Evans, Small, 8mm, Sterile
• 00889795018120: TITAN 3-D Wedge, Evans, Small, 6mm, Sterile
• 00889795050755: TRIAL HANDLE, EVANS, 10mm
• 00889795050748: TRIAL HANDLE, COTTON, 6mm
• 00889795020109: TITAN, Cotton Precision Screw Guide, Left
• 00889795020093: TITAN, Cotton Precision Screw Guide, Right
• 00889795020086: TITAN, Evans Precision Screw Guide, Left
• 00889795020079: TITAN, Evans Precision Screw Guide, Right
• 00889795020031: TITAN, Cotton Wedge Inserter
• 00889795020024: TITAN, Evans Wedge Inserter
• 00889795020017: Resection Guide Attachment Hex Handle
• 00889795020000: TITAN Caddy Lid
• 00889795019981: TITAN Instrument Caddy Base
• 00889795019998: TITAN Trial Caddy Base