FuzeFix Max FT FX-FT-2535

GUDID 00819034029778

Fully Threaded CompressionScrew FT 2.5mm x 35mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Primary Device ID	00819034029778
NIH Device Record Key	03e1981f-d8c3-4efa-b3be-a922779fb8df
Commercial Distribution Status	In Commercial Distribution
Brand Name	FuzeFix Max FT
Version Model Number	FX-FT-2535
Catalog Number	FX-FT-2535
Company DUNS	080307067
Company Name	FUSION ORTHOPEDICS, LLC
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819034029778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170038

FDA Product Code

HWC	Screw, Fixation, Bone

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

[00819034029778]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-04-26
Device Publish Date	2021-04-16

On-Brand Devices [FuzeFix Max FT]

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

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