14mm STAR E+ Sliding Core STAR Total Ankle

GUDID 00810028393554

Trilliant Surgical, LLC

Ankle prosthesis bearing
Primary Device ID00810028393554
NIH Device Record Key12fa987e-ec55-4d6f-a000-c6a4c07dff38
Commercial Distribution StatusIn Commercial Distribution
Brand Name14mm STAR E+ Sliding Core STAR Total Ankle
Version Model Number602-03-014
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
GS100810028393554 [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

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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