FuzeFix Chamfered Screws FX-CS-3035

GUDID 00840124509603

Chamfered Screw 3.0mm x 35mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)
Primary Device ID00840124509603
NIH Device Record Key8482ca54-d665-45a8-a6f6-7df49ec1668a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuzeFix Chamfered Screws
Version Model NumberFX-CS-3035
Catalog NumberFX-CS-3035
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840124509603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


[00840124509603]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-20
Device Publish Date2023-11-10

On-Brand Devices [FuzeFix Chamfered Screws]

00840124510340Chamfered Screw Cannulated Drill 3.0mm (2.1mm)
00840124510388Chamfered Screw 4.0mm x 60mm
00840124510371Chamfered Screw 4.0mm x 55mm
00840124510364Chamfered Screw 3.5mm x 60mm
00840124510357Chamfered Screw 3.5mm x 55mm
00840124510968Depth Gauge Chamfered Screw
00840124509726Chamfered Screw Reamer Cannulated 3.0mm
00840124509719Chamfered Screw Cannulated Driver 3.0mm
00840124509702Chamfered Screw 3.0mm x 55mm
00840124509696Chamfered Screw 3.0mm x 50mm
00840124509689Chamfered Screw 3.0mm x 48mm
00840124509672Chamfered Screw 3.0mm x 46mm
00840124509665Chamfered Screw 3.0mm x 45mm
00840124509658Chamfered Screw 3.0mm x 44mm
00840124509641Chamfered Screw 3.0mm x 42mm
00840124509634Chamfered Screw 3.0mm x 40mm
00840124509627Chamfered Screw 3.0mm x 38mm
00840124509610Chamfered Screw 3.0mm x 36mm
00840124509603Chamfered Screw 3.0mm x 35mm
00840124509597Chamfered Screw 3.0mm x 34mm
00840124509580Chamfered Screw 3.0mm x 32mm
00840124509573Chamfered Screw 3.0mm x 30mm
00840124509566Chamfered Screw 3.0mm x 28mm
00840124509559Chamfered Screw 3.0mm x 26mm
00840124509542Chamfered Screw 3.0mm x 24mm
00840124509535Chamfered Screw 3.0mm x 22mm
00840124509528Chamfered Screw 3.0mm x 20mm
00840124509511Chamfered Screw 3.0mm x 18mm
00840124509504Chamfered Screw 3.0mm x 16mm
00840124509498Chamfered Screw 3.0mm x 14mm
00840124509481Chamfered Screw 3.0mm x 12mm
00840124509474Chamfered Screw 3.0mm x 10mm
00840124509450Calibrated Wedge Burr, 2.2mm x 13mm
00840124509436Rectangle Shannon Burr, 2.0mm x 13mm
00840124509412Calibrated Shannon Burr, 2.0mm x 13mm
00840124509344Chamfered Screw Reamer Cannulated 4.0mm
00840124509337Chamfered Screw Reamer Cannulated 3.5mm
00840124509320Chamfered Screw Calibrated Drill Cannulated 4.0mm (3.2 mm)
00840124509313Chamfered Screw Calibrated Drill Cannulated 3.0mm (2.7mm)
00840124509306Cannulated Driver, CS 4.0mm
00840124509290Cannulated Driver, CS 3.5mm
00840124509283Chamfered Screw 3.5mm x 50mm
00840124509276Chamfered Screw 3.5mm x 45mm
00840124509269Chamfered Screw 3.5mm x 40mm
00840124509252Chamfered Screw 3.5mm x 35mm
00840124509245Chamfered Screw 3.5mm x 30mm
00840124509238Chamfered Screw 3.5mm x 28mm
00840124509221Chamfered Screw 3.5mm x 26mm
00840124509214Chamfered Screw 3.5mm x 24mm
00840124509207Chamfered Screw 3.5mm x 22mm

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