6mm STAR E+ Sliding Core STAR Total Ankle

GUDID 00810028393479

Trilliant Surgical, LLC

Ankle prosthesis bearing
Primary Device ID00810028393479
NIH Device Record Key0c7e369c-5238-4183-9c20-d29711fbe28a
Commercial Distribution StatusIn Commercial Distribution
Brand Name6mm STAR E+ Sliding Core STAR Total Ankle
Version Model Number602-03-006
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810028393479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NTGProsthesis, Ankle, Uncemented, Non-Constrained

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-14
Device Publish Date2024-08-06

Devices Manufactured by Trilliant Surgical, LLC

00850062461949 - Tibial Impactor Tips 2024-08-19
00810028393479 - 6mm STAR E+ Sliding Core STAR Total Ankle2024-08-14
00810028393479 - 6mm STAR E+ Sliding Core STAR Total Ankle2024-08-14
00810028393486 - 7mm STAR E+ Sliding Core STAR Total Ankle2024-08-14
00810028393493 - 8mm STAR E+ Sliding Core STAR Total Ankle2024-08-14
00810028393509 - 9mm STAR E+ Sliding Core STAR Total Ankle2024-08-14
00810028393516 - 10mm STAR E+ Sliding Core STAR Total Ankle2024-08-14
00810028393523 - 11mm STAR E+ Sliding Core STAR Total Ankle2024-08-14
00810028393530 - 12mm STAR E+ Sliding Core STAR Total Ankle2024-08-14

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