TalarLift™ STS TL-CY-0008

GUDID 00819034022304

Cylindrical ST Implant 8mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00819034022304
NIH Device Record Key5bd00869-f8d8-4440-b79e-b53b9cf3065b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTalarLift™ STS
Version Model NumberTL-CY-0008
Catalog NumberTL-CY-0008
Company DUNS080307067
Company NameFUSION ORTHOPEDICS, LLC
Device Count1
DM Exempttrue
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
GS100819034022304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819034022304]

Moist Heat or Steam Sterilization


[00819034022304]

Moist Heat or Steam Sterilization


[00819034022304]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-08

On-Brand Devices [TalarLift™ STS]

00819034027392Anatomical ST Implant 12mm (Sterile)
00819034027385Cylindrical ST Implant 12mm (Sterile)
00819034027378Conical ST Implant 12mm (Sterile)
00819034027361Anatomical ST Implant 12mm
00819034027354Cylindrical ST Implant 12mm
00819034027347Conical ST Implant 12mm
00819034022533Anatomical ST Implant 11mm (Sterile)
00819034022526Anatomical ST Implant 10mm (Sterile)
00819034022519Anatomical ST Implant 9mm (Sterile)
00819034022502Anatomical ST Implant 8mm (Sterile)
00819034022496Anatomical ST Implant 7mm (Sterile)
00819034022489Cylindrical ST Implant 11mm (Sterile)
00819034022472Cylindrical ST Implant 10mm (Sterile)
00819034022465Cylindrical ST Implant 9mm (Sterile)
00819034022458Cylindrical ST Implant 8mm (Sterile)
00819034022441Cylindrical ST Implant 7mm (Sterile)
00819034022434Conical ST Implant 11mm (Sterile)
00819034022427Conical ST Implant 10mm (Sterile)
00819034022410Conical ST Implant 8mm (Sterile)
00819034022403Conical ST Implant 9mm (Sterile)
00819034022397Conical ST Implant 7mm (Sterile)
00819034022380Anatomical ST Implant 11mm
00819034022373Anatomical ST Implant 10mm
00819034022366Anatomical ST Implant 8mm
00819034022359Anatomical ST Implant 9mm
00819034022342Anatomical ST Implant 7mm
00819034022335Cylindrical ST Implant 11mm
00819034022328Cylindrical ST Implant 10mm
00819034022311Cylindrical ST Implant 9mm
00819034022304Cylindrical ST Implant 8mm
00819034022298Cylindrical ST Implant 7mm
00819034022281Conical ST Implant 11mm
00819034022274Conical ST Implant 10mm
00819034022267Conical ST Implant 9mm
00819034022250Conical ST Implant 8mm
00819034022243Conical ST Implant 7mm
00819034022229(not in use)
00819034022212(not in use)
00819034022205(not in use)
00819034022199(not in use)
00819034022182(not in use)
00819034022175(not in use)
00819034022168(not in use)
00819034022151(not in use)
00819034022021(not in use)
00819034021611(not in use)

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