STAR PSI Tibia Anatomical Model

GUDID 00810028393448

Trilliant Surgical, LLC

Custom-made orthopaedic/craniofacial surgical guide
Primary Device ID00810028393448
NIH Device Record Key48da10ba-d98b-413a-b817-dc5876a9d17f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTAR PSI Tibia Anatomical Model
Version Model Number601-01-001
Company DUNS828829072
Company NameTrilliant Surgical, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810028393448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NTGProsthesis, Ankle, Uncemented, Non-Constrained

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-08
Device Publish Date2022-11-30

Devices Manufactured by Trilliant Surgical, LLC

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 Ankle2024-11-11
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
00810028394490 - Spare Caddy, Gen II STAR Ankle 2024-11-11

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