TalarLift STS TN-TL-3012

GUDID 00819034027422

Trial Cylindrical 12mm

FUSION ORTHOPEDICS, LLC

Orthopaedic implant/trial-implant holder, single-use
Primary Device ID00819034027422
NIH Device Record Keya80a42a4-8ed4-4ba2-b50b-807bc8266eb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTalarLift STS
Version Model NumberTN-TL-3012
Catalog NumberTN-TL-3012
Company DUNS080307067
Company NameFUSION ORTHOPEDICS, LLC
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100819034027422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


[00819034027422]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-07
Device Publish Date2019-04-29

On-Brand Devices [TalarLift STS ]

00819034027422Trial Cylindrical 12mm
00819034027415Trial Anatomical 12mm
00819034027408Trial Conical 12mm
00819034022724Trial Cylindrical 11mm
00819034022717Trial Cylindrical 10mm
00819034022700Trial Cylindrical 9mm
00819034022694Trial Cylindrical 8mm
00819034022687Trial Cylindrical 7mm
00819034022663Trial Anatomical 10mm
00819034022656Trial Anatomical 9mm
00819034022649Trial Anatomical 8mm
00819034022632Trial Anatomical 7mm
00819034022625Trial Conical 11mm
00819034022618Trial Conical 10mm
00819034022601Trial Conical 9mm
00819034022595Trial Conical 8mm
00819034022588Trial Conical 7mm
00819034022571Probe 5.0mm
00819034022564Driver STS 131mm
00819034022557Removal Driver STS 131mm
00819034022540CoCR Implant Rod
00840124505100STS Removal Driver Cannulated

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