Patient Specific Talus Spacer AOPSTT-XXXXS

GUDID 00889795128768

Patient Specific Talus Trial, Small, Nylon

PARAGON 28, INC.

Coated ankle talus prosthesis

• Primary Device ID: 00889795128768
• NIH Device Record Key: 8b8f157c-8223-42bb-82a0-e3a6f75a6732
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Specific Talus Spacer
• Version Model Number: AOPSTT-XXXXS
• Catalog Number: AOPSTT-XXXXS
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	00889795128768 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H200001

FDA Product Code

• QNN: Prosthesis, Total Talus Replacement, Metal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-15
• Device Publish Date: 2024-03-07

On-Brand Devices [Patient Specific Talus Spacer]

• 00889795137210: Patient Specific Talus Spacer, Small, CoCr
• 00889795137203: Patient Specific Talus Spacer, Nominal, CoCr
• 00889795137197: Patient Specific Talus Spacer, Large, CoCr
• 00889795128782: Patient Specific Talus Trial, Large, Nylon
• 00889795128775: Patient Specific Talus Trial, Nominal, Nylon
• 00889795128768: Patient Specific Talus Trial, Small, Nylon
• 00889795128133: Patient Specific Talus Spacer, Small, Titanium
• 00889795128126: Patient Specific Talus Spacer, Nominal, Titanium
• 00889795128119: Patient Specific Talus Spacer, Large, Titanium