4.0mm x 48mm Gridlock Ankle Syndesmotic Screw LP

GUDID 00812926027272

TRILLIANT SURGICAL, LTD.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00812926027272
NIH Device Record Keye059339f-42bf-4c35-a3e5-3a2b1accb6c0
Commercial Distribution StatusIn Commercial Distribution
Brand Name4.0mm x 48mm Gridlock Ankle Syndesmotic Screw LP
Version Model Number306-41-048
Company DUNS828829072
Company NameTRILLIANT SURGICAL, LTD.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter
Length48 Millimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100812926027272 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


[00812926027272]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-13

Devices Manufactured by TRILLIANT SURGICAL, LTD.

00810028391512 - Arsenal Petite MPJ Plate, L, 0°2021-09-13
00810028391529 - Arsenal Petite MPJ Plate, R, 0°2021-09-13
00810028391536 - Arsenal Petite MPJ Plate, L, 5°2021-09-13
00810028391543 - Arsenal Petite MPJ Plate, R, 5°2021-09-13
00810028391550 - Arsenal Short 5th Met Hook Plate, L2021-09-13
00810028391567 - Arsenal Short 5th Met Hook Plate, R2021-09-13
00810028391574 - Arsenal U-Plate, Small, L2021-09-13
00810028391581 - Arsenal U-Plate, Small, R2021-09-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.