3.5mm x 16mm Gridlock Ankle Locking Screw

GUDID 00812926026114

TRILLIANT SURGICAL, LTD.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00812926026114
NIH Device Record Key19adea7c-8047-4032-820a-4af33c5a4fb3
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm x 16mm Gridlock Ankle Locking Screw
Version Model Number305-35-016
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter
Outer Diameter3.5 Millimeter
Length16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100812926026114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


[00812926026114]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

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