FuzeFix™ Large FX-HD-5528

GUDID 00819034023844

HD 5.5mm x 28mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00819034023844
NIH Device Record Key0c298597-5057-4af3-a4d4-c26ac9347b99
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuzeFix™ Large
Version Model NumberFX-HD-5028
Catalog NumberFX-HD-5528
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
GS100819034023844 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819034023844]

Moist Heat or Steam Sterilization


[00819034023844]

Moist Heat or Steam Sterilization


[00819034023844]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-15

On-Brand Devices [FuzeFix™ Large]

00819034026852HLL 7.0mm x 130mm Long Thread
00819034026845HLL 7.0mm x 125mm Long Thread
00819034026838HLL 7.0mm x 115mm Long Thread
00819034026821HLL 7.0mm x 120mm Long Thread
00819034026814HLL 7.0mm x 110mm Long Thread
00819034026807HLL 7.0mm x 105mm Long Thread
00819034026791HLL 7.0mm x 100mm Long Thread
00819034026784HLL 7.0mm x 95mm Long Thread
00819034026777HDL 7.0mm x 50mm Long Thread
00819034026760HD 7.0mm x 110mm Short Thread
00819034026753HD 7.0mm x 80mm Short Thread
00819034026746HD 5.0mm x 90mm
00819034026739HD 5.5mm x 85mm
00819034026722HD 5.5mm x 75mm
00819034026715HD 5.5mm x 80mm
00819034026708HD 5.5mm x 48mm
00819034026111HD 5.5mm x 46mm
00819034025688HL 7.0mm x 130mm Short Thread
00819034025671HL 7.0mm x 125mm Short Thread
00819034025664HL 7.0mm x 120mm Short Thread
00819034025657HL 7.0mm x 115mm Short Thread
00819034025640HL 7.0mm x 110mm Short Thread
00819034025633HL 7.0mm x 105mm Short Thread
00819034025626HL 7.0mm x 100mm Short Thread
00819034025619HL 7.0mm x 95mm Short Thread
00819034025602HL 7.0mm x 90mm Short Thread
00819034025596HL 7.0mm x 85mm Short Thread
00819034025589HL 7.0mm x 80mm Short Thread
00819034025572HL 7.0mm x 75mm Short Thread
00819034025565HL 7.0mm x 70mm Short Thread
00819034025558HL 7.0mm x 65mm Short Thread
00819034025541HL 7.0mm x 60mm Short Thread
00819034025534HL 7.0mm x 55mm Short Thread
00819034025527HL 7.0mm x 50mm Short Thread
00819034025510HL 7.0mm x 45mm Short Thread
00819034025503HL 7.0mm x 40mm Short Thread
00819034025497HL 7.0mm x 35mm Short Thread
00819034025480HL 7.0mm x 30mm Short Thread
00819034025190HL 5.5mm x 70mm
00819034025183HL 5.5mm x 65mm
00819034025176HL 5.5mm x 60mm
00819034025169HL 5.5mm x 55mm
00819034025152HL 5.5mm x 50mm
00819034025145HL 5.5mm x 42mm
00819034025138HL 5.5mm x 40mm
00819034025121HL 5.5mm x 38mm
00819034025114HL 5.5mm x 36mm
00819034025091HL 5.5mm x 32mm
00819034025084HL 5.5mm x 30mm
00819034025077HL 5.5mm x 28mm

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