FuzeFix™ Twist Off FX-TW-2013

GUDID 00819034021666

TW 2.0mm x 13mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00819034021666
• NIH Device Record Key: fd1b6dd0-16ba-4b09-8dfc-29ddb9b2cc9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix™ Twist Off
• Version Model Number: FX-TW-2013
• Catalog Number: FX-TW-2013
• 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	00819034021666 [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

[00819034021666]

Moist Heat or Steam Sterilization

[00819034021666]

Moist Heat or Steam Sterilization

[00819034021666]

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: 2017-11-15

On-Brand Devices [FuzeFix™ Twist Off]

• 00819034021826: TW 2.5mm x 22mm
• 00819034021819: TW 2.5mm x 20mm
• 00819034021802: TW 2.5mm x 18mm
• 00819034021796: TW 2.5mm x 16mm
• 00819034021789: TW 2.5mm x 15mm
• 00819034021772: TW 2.5mm x 14mm
• 00819034021765: TW 2.5mm x 13mm
• 00819034021758: TW 2.5mm x 12mm
• 00819034021741: TW 2.5mm x 11mm
• 00819034021734: TW 2.5mm x 10mm
• 00819034021727: TW 2.0mm x 22mm
• 00819034021710: TW 2.0mm x 20mm
• 00819034021703: TW 2.0mm x 18mm
• 00819034021697: TW 2.0mm x 16mm
• 00819034021680: TW 2.0mm x 15mm
• 00819034021673: TW 2.0mm x 14mm
• 00819034021666: TW 2.0mm x 13mm
• 00819034021659: TW 2.0mm x 12mm
• 00819034021642: TW 2.0mm x 11mm
• 00819034021635: TW 2.0mm x 10mm