FuzeFix™ Max FT FX-FT-4528

GUDID 00819034022878

FT 4.5mm x 28mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00819034022878
NIH Device Record Keyd711d7fc-2bd5-48c3-aaf5-3f415a919349
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuzeFix™ Max FT
Version Model NumberFX-FT-4528
Catalog NumberFX-FT-4528
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
GS100819034022878 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819034022878]

Moist Heat or Steam Sterilization


[00819034022878]

Moist Heat or Steam Sterilization


[00819034022878]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

On-Brand Devices [FuzeFix™ Max FT]

00819034023035FT 4.5mm x 60mm
00819034023028FT 4.5mm x 58mm
00819034023011FT 4.5mm x 56mm
00819034023004FT 4.5mm x 54mm
00819034022991FT 4.5mm x 52mm
00819034022984FT 4.5mm x 50mm
00819034022977FT 4.5mm x 48mm
00819034022960FT 4.5mm x 46mm
00819034022953FT 4.5mm x 44mm
00819034022946FT 4.5mm x 42mm
00819034022939FT 4.5mm x 40mm
00819034022922FT 4.5mm x 38mm
00819034022915FT 4.5mm x 36mm
00819034022908FT 4.5mm x 34mm
00819034022892FT 4.5mm x 32mm
00819034022885FT 4.5mm x 30mm
00819034022878FT 4.5mm x 28mm
00819034022861FT 4.5mm x 26mm
00819034022854FT 4.5mm x 24mm
00819034022847FT 4.5mm x 22mm
00819034022830FT 4.5mm x 20mm
00819034022823FT 3.5mm x 50mm
00819034022816FT 3.5mm x 48mm
00819034022809FT 3.5mm x 46mm
00819034022793FT 3.5mm x 44mm
00819034022786FT 3.5mm x 42mm
00819034022779FT 2.5mm x 40mm
00819034022762FT 2.5mm x 38mm
00819034022755FT 2.5mm x 36mm
00819034022748FT 2.5mm x 34mm
00819034022731FT 2.5mm x 32mm
00819034022144FT 3.5mm x 40mm
00819034022137FT 3.5mm x 38mm
00819034022120FT 3.5mm x 36mm
00819034022113FT 3.5mm x 34mm
00819034022106FT 3.5mm x 32mm
00819034022090FT 3.5mm x 30mm
00819034022083FX-FT-3528
00819034022076FT 3.5mm x 26mm
00819034022069FT 3.5mm x 24mm
00819034022052FT 3.5mm x 22mm
00819034022045FT 3.5mm x 20mm
00819034022038FT 3.5mm x 18mm
00819034022014FT 3.5mm x 16mm
00819034022007FT 3.5mm x 14mm
00819034021994FT 3.5mm x 12mm
00819034021987FT 2.5mm x 30mm
00819034021970FT 2.5mm x 28mm
00819034021963FT 2.5mm x 26mm
00819034021956FT 2.5mm x 24mm

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