3S Hemi Implant, Large, Non-Sterile

GUDID 00812926020099

TRILLIANT SURGICAL, LTD.

Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis

Primary Device ID	00812926020099
NIH Device Record Key	9cb21476-b255-48b9-bab6-c9f261860375
Commercial Distribution Status	In Commercial Distribution
Brand Name	3S Hemi Implant, Large, Non-Sterile
Version Model Number	101-00-003
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	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter
Width	22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812926020099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K072922

FDA Product Code

KWD	Prosthesis, Toe, Hemi-, Phalangeal