FuzeFix Mini

GUDID 00819034021543

K-Wire Threaded 1.1mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone wire
Primary Device ID00819034021543
NIH Device Record Key5bfceab4-8ffd-4030-8ae9-4ec41d24de1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuzeFix Mini
Version Model NumberCD-FX-0511
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
GS100819034021543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819034021543]

Moist Heat or Steam Sterilization


[00819034021543]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-29
Device Publish Date2019-04-19

On-Brand Devices [FuzeFix Mini]

00819034023202Screw Holding Forceps small
00819034023172Depth Gauge HL
00819034023165Depth Gauge HD
00819034022236K-Wire Threaded 0.9 mm
00819034021628Screw Extractor Rod 3.0mm and 4.0mm
00819034021604Removal Driver Torx 4.0mm
00819034021598Removal Driver Torx 3.0mm
00819034021581Driver Torx 4.0mm
00819034021574Driver Torx 3.0mm
00819034021567Driver Torx 2.5mm
00819034021550Driver Torx 2.0mm
00819034021543K-Wire Threaded 1.1mm
00819034021536K-Wire Standard 0.9mm
00819034021529K-Wire Standard 1.1 mm
00819034021512Proximal Reamer Headless 4.0mm
00819034021505Proximal Reamer Headless 3.0mm
00819034021499Proximal Reamer Headless 2.5mm
00819034021482Proximal Reamer Headless 2.0mm
00819034021475Proximal Reamer Cannulated 4.0 mm
00819034021468Proximal Reamer Cannulated 3.0mm
00819034021451Proximal Reamer Cannulated 2.5mm
00819034021444Proximal Reamer Cannulated 2.0 mm
00819034021437Calibrated Drill Cannulated 2.6 mm
00819034021420Calibrated Drill Cannulated 2.2mm
00819034021413Calibrated Drill Cannulated 1.9mm
00819034021406Calibrated Drill Cannulated 1.7mm
00819034029846Headless Screw HL 2.0mm x 37mm
00819034029839Headless Screw HL 2.0mm x 32mm
00840124506909Smooth Washer 4.0mm
00840124506893Spiked Washer 3.0mnm
00840124507166Cannulated Screw HD 4.0mm x 55mm
00840124506886Cannulated Screw HD 4.00mm x 60mm
00840124506879Cannulated Screw HD 4.0mm x 58mm
00840124506862Cannulated Screw HD 4.0mm x 56mm
00840124506855Cannulated Screw HD 4.0mm x 54mm
00840124506848Cannulated Screw HD 4.0mm x 52mm
00840124506831HL 4.0mm x 60mm
00840124506824HL 4.0mm x 58mm
00840124506817HL 4.0mm x 56mm
00840124506701Tissue Protector Handle
00840124506633Tissue Protector 4.0mm
00840124506626Tissue Protector 3.0mm
00840124506619Tissue Protector 2.5mm
00840124506602Tissue Protector 2.0mm
00840124501812Driver Handle Non-Ratcheting
00840124501805Driver Handle Ratcheting
00819034029297K-Wire Double Trocar 0.9mm
00819034029280K-Wire Double Trocar 1.1mm
00840124507173HL 4.0mm x 55mm
00840124506800HL 4.0mm x 54mm

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