FuzeFix Max FT CD-FT-2035

GUDID 00819034023080

Cannulated Reamer 3.5mm

FUSION ORTHOPEDICS, LLC

Surgical countersink, single-use
Primary Device ID00819034023080
NIH Device Record Key4f4b1f88-e514-499a-a727-058f4265c671
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuzeFix Max FT
Version Model NumberCD-FT-2035
Catalog NumberCD-FT-2035
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
GS100819034023080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819034023080]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-30
Device Publish Date2019-04-22

On-Brand Devices [FuzeFix Max FT]

00819034028344K-Wire Threaded 1.4mm
00819034028337K-Wire Standard 1.4mm
00819034023189Depth Gauge FT
00819034023158Removal Driver 4.5mm
00819034023141Removal Driver 3.5mm
00819034023134Removal Driver 2.5mm
00819034023127Torx Driver 4.5mm
00819034023110Torx Driver 3.5mm
00819034023103Torx Driver 2.5mm
00819034023097Cannulated Reamer 4.5mm
00819034023080Cannulated Reamer 3.5mm
00819034023073Cannulated Reamer 2.5mm
00819034023066Calibrated Drill Cannulated 3.0mm
00819034023059Calibrated Drill Cannulated 2.1mm
00819034023042Calibrated Drill Cannulated 1.7mm
00819034029822Fully Threaded CompressionScrew FT 3.5mm x 55mm
00819034029815Fully Threaded CompressionScrew FT 3.5mm x 45mm
00819034029808Fully Threaded CompressionScrew FT 3.5mm x 35mm
00819034029792Fully Threaded CompressionScrew FT 2.5mm x 50mm
00819034029785Fully Threaded CompressionScrew FT 2.5mm x 45mm
00819034029778Fully Threaded CompressionScrew FT 2.5mm x 35mm
00840124506664Tissue Protector 3.5mm
00840124506657Tissue Protector 4.5mm
00840124506640Tissue Protector 2.5mm

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