TalarLift STS TN-TL-2008

GUDID 00819034022649

Trial Anatomical 8mm

FUSION ORTHOPEDICS, LLC

Orthopaedic implant/trial-implant holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use

Primary Device ID	00819034022649
NIH Device Record Key	d208550b-9fd5-436a-864e-61339b6a5a86
Commercial Distribution Status	In Commercial Distribution
Brand Name	TalarLift STS
Version Model Number	TN-TL-2008
Catalog Number	TN-TL-2008
Company DUNS	080307067
Company Name	FUSION ORTHOPEDICS, LLC
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	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819034022649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170624

FDA Product Code

HWC	Screw, Fixation, Bone