FuzeFix Jones TN-JO-7000

GUDID 00840124501997

Guide 1.6mm and 3.2mm

FUSION ORTHOPEDICS, LLC

Surgical drill guide, single-use
Primary Device ID00840124501997
NIH Device Record Key27671367-5b90-4401-8ad4-1f9f22892b91
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuzeFix Jones
Version Model NumberTN-JO-7000
Catalog NumberTN-JO-7000
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
GS100840124501997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840124501997]

Moist Heat or Steam Sterilization


[00840124501997]

Moist Heat or Steam Sterilization


[00840124501997]

Moist Heat or Steam Sterilization


[00840124501997]

Moist Heat or Steam Sterilization


[00840124501997]

Moist Heat or Steam Sterilization


[00840124501997]

Moist Heat or Steam Sterilization


[00840124501997]

Moist Heat or Steam Sterilization


[00840124501997]

Moist Heat or Steam Sterilization


[00840124501997]

Moist Heat or Steam Sterilization


[00840124501997]

Moist Heat or Steam Sterilization


[00840124501997]

Moist Heat or Steam Sterilization


[00840124501997]

Moist Heat or Steam Sterilization


[00840124501997]

Moist Heat or Steam Sterilization


[00840124501997]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-28
Device Publish Date2020-12-18

On-Brand Devices [FuzeFix Jones]

00840124502000Depth Gauge Jones
00840124501997Guide 1.6mm and 3.2mm
00840124501980Torx Driver 4.5mm
00840124501973Cannulated Proximal Reamer 4.5mm
00840124501966Calibrated Drill Cannulated 3.2mm
00840124501959Solid Variable Pitch Screw JO 5.5mm x 70mm
00840124501942Solid Variable Pitch Screw JO 5.5mm x 65mm
00840124501935Solid Variable Pitch Screw JO 5.5mm x 60mm
00840124501928Solid Variable Pitch Screw JO 5.5mm x 55mm
00840124501911Solid Variable Pitch Screw JO 5.5mm x 50mm
00840124501904Solid Variable Pitch Screw JO 5.5mm x 45mm
00840124501898Solid Variable Pitch Screw JO 5.5mm x 40mm
00840124501881Solid Variable Pitch Screw JO 4.5mm x 70mm
00840124501874Solid Variable Pitch Screw JO 4.5mm x 65mm
00840124501867Solid Variable Pitch Screw JO 4.5mm x 60mm
00840124501850Solid Variable Pitch Screw JO 4.5mm x 55mm
00840124501843Solid Variable Pitch Screw JO 4.5mm x 50mm
00840124501836Solid Variable Pitch Screw JO 4.5mm x 45mm
00840124501829Solid Variable Pitch Screw JO 4.5mm x 40mm
00840124507357Guide 4.5mm and 5.5mm
00840124507340Headed Jones 5.5mm x 70mm
00840124507333Headed Screws 5.5mm x 65mm
00840124507326Headed Screws 5.5mm x 60mm
00840124507319Headed Screws 5.5mm x 55mm
00840124507302Headed Screws 5.5mm x 50mm
00840124507296Headed Screw 5.5mm x 45mm
00840124507289Headed Screws 5.5mm x 40mm
00840124507272Headed Screw 4.5mm x 70mm
00840124507265Headed Jones 4.5mm x 65mm
00840124507258Headed Screw 4.5mm x 60mm
00840124507241Headed Screw 5.5mm x 55mm
00840124507234Headed Screw 4.5mm x 50mm
00840124507227Headed Screw 4.5mm x 45mm
00840124507210Headed Screw 4.5mm x 40mm
008401245072035.5mm Cannulated Tap
008401245071974.5mm Cannulated Tap
008401245082175.5mm Cannulated Tap
00840124507180Headed Tray
00840124513686Jones Headless Screw Tray
00840124509405K-Wire Standard 1.6mm

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