FuzeFix™ Mini FX-HD-4028

GUDID 00819034020591

HD 4.0mm x 28mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00819034020591
• NIH Device Record Key: abea48d6-0d88-4834-8703-8366f3855c50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix™ Mini
• Version Model Number: FX-HD-4028
• Catalog Number: FX-HD-4028
• 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	00819034020591 [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

[00819034020591]

Moist Heat or Steam Sterilization

[00819034020591]

Moist Heat or Steam Sterilization

[00819034020591]

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: 2017-11-03

On-Brand Devices [FuzeFix™ Mini]

• 00819034021390: HL 4.0mm x 50mm
• 00819034021383: HL 4.0mm x 48mm
• 00819034021376: HL 4.0mm x 46mm
• 00819034021369: HL 4.0mm x 44mm
• 00819034021352: HL 4.0mm x 42mm
• 00819034021345: HL 4.0mm x 40mm
• 00819034021338: HL 4.0mm x 38mm
• 00819034021321: HL 4.0mm x 36mm
• 00819034021314: HL 4.0mm x 34mm
• 00819034021307: HL 4.0mm x 32mm
• 00819034021291: HL 4.0mm x 30mm
• 00819034021284: HL 4.0mm x 28mm
• 00819034021277: HL 4.0mm x 26mm
• 00819034021260: HL 4.0mm x 24mm
• 00819034021253: HL 4.0mm x 22mm
• 00819034021246: HL 4.0mm x 20mm
• 00819034021239: HL 4.0mm x 18mm
• 00819034021222: HL 4.0mm x 14mm
• 00819034021215: HL 4.0mm x 16mm
• 00819034021208: HL 4.0mm x 12mm
• 00819034021192: HL 3.0mm x 50mm
• 00819034021185: HL 3.0mm x 45mm
• 00819034021178: HL 3.0mm x 40mm
• 00819034021161: HL 3.0mm x 38mm
• 00819034021154: HL 3.0mm x 36mm
• 00819034021147: HL 3.0mm x 34mm
• 00819034021130: HL 3.0mm x 32mm
• 00819034021123: HL 3.0mm x 30mm
• 00819034021116: HL 3.0mm x 28mm
• 00819034021109: HL 3.0mm x 26mm
• 00819034021093: HL 3.0mm x 24mm
• 00819034021086: HL 3.0mm x 22mm
• 00819034021079: HL 3.0mm x 20mm
• 00819034021062: HL 3.0mm x 18mm
• 00819034021055: HL 3.0mm x 16mm
• 00819034021048: HL 3.0mm x 14mm
• 00819034021031: HL 3.0mm x 12mm
• 00819034021024: HL 3.0mm x 10mm
• 00819034021017: HL 2.5mm x 50mm
• 00819034021000: HL 2.5mm x 45mm
• 00819034020997: HL 2.5mm x 40mm
• 00819034020980: HL 2.5mm x 35mm
• 00819034020973: HL 2.5mm x 30mm
• 00819034020966: HL 2.5mm x 28mm
• 00819034020959: HL 2.5mm x 26mm
• 00819034020942: HL 2.5mm x 24mm
• 00819034020935: HL 2.5mm x 22mm
• 00819034020928: HL 2.5mm x 20mm
• 00819034020911: HL 2.5mm x 18mm
• 00819034020904: HL 2.5mm x 16mm