STAR PSI Tibia Anatomical Model

GUDID 00810028393448

Trilliant Surgical, LLC

Custom-made orthopaedic/craniofacial surgical guide

• Primary Device ID: 00810028393448
• NIH Device Record Key: 48da10ba-d98b-413a-b817-dc5876a9d17f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAR PSI Tibia Anatomical Model
• Version Model Number: 601-01-001
• Company DUNS: 828829072
• Company Name: Trilliant Surgical, LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810028393448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050050

FDA Product Code

• NTG: Prosthesis, Ankle, Uncemented, Non-Constrained

Sterilization

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

[00810028393448]

Moist Heat or Steam Sterilization

[00810028393448]

Moist Heat or Steam Sterilization

[00810028393448]

Moist Heat or Steam Sterilization

[00810028393448]

Moist Heat or Steam Sterilization

[00810028393448]

Moist Heat or Steam Sterilization

[00810028393448]

Moist Heat or Steam Sterilization

[00810028393448]

Moist Heat or Steam Sterilization

[00810028393448]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-11-30

Devices Manufactured by Trilliant Surgical, LLC

• 00190446898269 - Stabilization: 2024-12-26 Arsenal Ankle Drill Tower Modular Bracket
• 00810028394414 - STAR Instrument Case Lid, Gen II STAR Ankle: 2024-11-11
• 00810028394438 - Instrument Case #3, Gen II STAR Ankle: 2024-11-11
• 00810028394445 - Right Talar Cut Guide Assy, Gen II STAR Ankle: 2024-11-11
• 00810028394452 - Talar Cut Guide Caddy Lid, Gen II STAR Ankle: 2024-11-11
• 00810028394469 - Left Talar Cut Guide Caddy Assy, Gen II STAR Ankle: 2024-11-11
• 00810028394476 - PE Trial Caddy Assy, Gen II: 2024-11-11
• 00810028394483 - PE Trial Caddy Lid, Gen II STAR Ankle: 2024-11-11