9mm Disco Subtalar Implant

GUDID 00812926020310

TRILLIANT SURGICAL, LTD.

Subtalar implant, non-bioabsorbable, sterile

Primary Device ID	00812926020310
NIH Device Record Key	d34295d1-fd4c-469b-acde-ff6c891f2fbd
Commercial Distribution Status	In Commercial Distribution
Brand Name	9mm Disco Subtalar Implant
Version Model Number	102-20-009
Company DUNS	828829072
Company Name	TRILLIANT SURGICAL, LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Width	9 Millimeter
Width	9 Millimeter
Width	9 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter
Height	17 Millimeter
Width	9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812926020310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K111834

FDA Product Code

HWC	Screw, Fixation, Bone

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

[00812926020310]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-01-27

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