12mm Disco Subtalar Implant

GUDID 00812926020341

TRILLIANT SURGICAL, LTD.

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Primary Device ID	00812926020341
NIH Device Record Key	f3c9ae02-eb76-481b-980f-918b6e4667c4
Commercial Distribution Status	In Commercial Distribution
Brand Name	12mm Disco Subtalar Implant
Version Model Number	102-20-012
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

Height	23 Millimeter
Height	23 Millimeter
Height	23 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter
Width	12 Millimeter
Height	23 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812926020341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K111834

FDA Product Code

HWC	Screw, Fixation, Bone