FuzeFix™ Mini FX-HD-2012

GUDID 00819034020034

HD 2.0mm x 12mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00819034020034
NIH Device Record Key1bd14273-8fb9-462a-8238-ad03e0ca207b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuzeFix™ Mini
Version Model NumberFX-HD-2012
Catalog NumberFX-HD-2012
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
GS100819034020034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819034020034]

Moist Heat or Steam Sterilization


[00819034020034]

Moist Heat or Steam Sterilization


[00819034020034]

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

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00819034021130HL 3.0mm x 32mm
00819034021123HL 3.0mm x 30mm
00819034021116HL 3.0mm x 28mm
00819034021109HL 3.0mm x 26mm
00819034021093HL 3.0mm x 24mm
00819034021086HL 3.0mm x 22mm
00819034021079HL 3.0mm x 20mm
00819034021062HL 3.0mm x 18mm
00819034021055HL 3.0mm x 16mm
00819034021048HL 3.0mm x 14mm
00819034021031HL 3.0mm x 12mm
00819034021024HL 3.0mm x 10mm
00819034021017HL 2.5mm x 50mm
00819034021000HL 2.5mm x 45mm
00819034020997HL 2.5mm x 40mm
00819034020980HL 2.5mm x 35mm
00819034020973HL 2.5mm x 30mm
00819034020966HL 2.5mm x 28mm
00819034020959HL 2.5mm x 26mm
00819034020942HL 2.5mm x 24mm
00819034020935HL 2.5mm x 22mm
00819034020928HL 2.5mm x 20mm
00819034020911HL 2.5mm x 18mm
00819034020904HL 2.5mm x 16mm

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