FuzeFix™ Max FT FX-FT-3548

GUDID 00819034022816

FT 3.5mm x 48mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00819034022816
• NIH Device Record Key: 1fc50119-e156-4143-8543-08729ea58160
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix™ Max FT
• Version Model Number: FX-FT-3548
• Catalog Number: FX-FT-3548
• 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	00819034022816 [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

[00819034022816]

Moist Heat or Steam Sterilization

[00819034022816]

Moist Heat or Steam Sterilization

[00819034022816]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-06

On-Brand Devices [FuzeFix™ Max FT]

• 00819034023035: FT 4.5mm x 60mm
• 00819034023028: FT 4.5mm x 58mm
• 00819034023011: FT 4.5mm x 56mm
• 00819034023004: FT 4.5mm x 54mm
• 00819034022991: FT 4.5mm x 52mm
• 00819034022984: FT 4.5mm x 50mm
• 00819034022977: FT 4.5mm x 48mm
• 00819034022960: FT 4.5mm x 46mm
• 00819034022953: FT 4.5mm x 44mm
• 00819034022946: FT 4.5mm x 42mm
• 00819034022939: FT 4.5mm x 40mm
• 00819034022922: FT 4.5mm x 38mm
• 00819034022915: FT 4.5mm x 36mm
• 00819034022908: FT 4.5mm x 34mm
• 00819034022892: FT 4.5mm x 32mm
• 00819034022885: FT 4.5mm x 30mm
• 00819034022878: FT 4.5mm x 28mm
• 00819034022861: FT 4.5mm x 26mm
• 00819034022854: FT 4.5mm x 24mm
• 00819034022847: FT 4.5mm x 22mm
• 00819034022830: FT 4.5mm x 20mm
• 00819034022823: FT 3.5mm x 50mm
• 00819034022816: FT 3.5mm x 48mm
• 00819034022809: FT 3.5mm x 46mm
• 00819034022793: FT 3.5mm x 44mm
• 00819034022786: FT 3.5mm x 42mm
• 00819034022779: FT 2.5mm x 40mm
• 00819034022762: FT 2.5mm x 38mm
• 00819034022755: FT 2.5mm x 36mm
• 00819034022748: FT 2.5mm x 34mm
• 00819034022731: FT 2.5mm x 32mm
• 00819034022144: FT 3.5mm x 40mm
• 00819034022137: FT 3.5mm x 38mm
• 00819034022120: FT 3.5mm x 36mm
• 00819034022113: FT 3.5mm x 34mm
• 00819034022106: FT 3.5mm x 32mm
• 00819034022090: FT 3.5mm x 30mm
• 00819034022083: FX-FT-3528
• 00819034022076: FT 3.5mm x 26mm
• 00819034022069: FT 3.5mm x 24mm
• 00819034022052: FT 3.5mm x 22mm
• 00819034022045: FT 3.5mm x 20mm
• 00819034022038: FT 3.5mm x 18mm
• 00819034022014: FT 3.5mm x 16mm
• 00819034022007: FT 3.5mm x 14mm
• 00819034021994: FT 3.5mm x 12mm
• 00819034021987: FT 2.5mm x 30mm
• 00819034021970: FT 2.5mm x 28mm
• 00819034021963: FT 2.5mm x 26mm
• 00819034021956: FT 2.5mm x 24mm