FuzeFix™ Large FX-HL-5590

GUDID 00819034024681

HL 5.5mm x 90mm

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: 00819034024681
• NIH Device Record Key: 69e333ea-e76d-44b7-90a5-e0420e5936f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix™ Large
• Version Model Number: FX-HL-5090
• Catalog Number: FX-HL-5590
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: false
• 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	00819034024681 [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

[00819034024681]

Moist Heat or Steam Sterilization

[00819034024681]

Moist Heat or Steam Sterilization

[00819034024681]

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: 2017-11-13

On-Brand Devices [FuzeFix™ Large]

• 00819034026852: HLL 7.0mm x 130mm Long Thread
• 00819034026845: HLL 7.0mm x 125mm Long Thread
• 00819034026838: HLL 7.0mm x 115mm Long Thread
• 00819034026821: HLL 7.0mm x 120mm Long Thread
• 00819034026814: HLL 7.0mm x 110mm Long Thread
• 00819034026807: HLL 7.0mm x 105mm Long Thread
• 00819034026791: HLL 7.0mm x 100mm Long Thread
• 00819034026784: HLL 7.0mm x 95mm Long Thread
• 00819034026777: HDL 7.0mm x 50mm Long Thread
• 00819034026760: HD 7.0mm x 110mm Short Thread
• 00819034026753: HD 7.0mm x 80mm Short Thread
• 00819034026746: HD 5.0mm x 90mm
• 00819034026739: HD 5.5mm x 85mm
• 00819034026722: HD 5.5mm x 75mm
• 00819034026715: HD 5.5mm x 80mm
• 00819034026708: HD 5.5mm x 48mm
• 00819034026111: HD 5.5mm x 46mm
• 00819034025688: HL 7.0mm x 130mm Short Thread
• 00819034025671: HL 7.0mm x 125mm Short Thread
• 00819034025664: HL 7.0mm x 120mm Short Thread
• 00819034025657: HL 7.0mm x 115mm Short Thread
• 00819034025640: HL 7.0mm x 110mm Short Thread
• 00819034025633: HL 7.0mm x 105mm Short Thread
• 00819034025626: HL 7.0mm x 100mm Short Thread
• 00819034025619: HL 7.0mm x 95mm Short Thread
• 00819034025602: HL 7.0mm x 90mm Short Thread
• 00819034025596: HL 7.0mm x 85mm Short Thread
• 00819034025589: HL 7.0mm x 80mm Short Thread
• 00819034025572: HL 7.0mm x 75mm Short Thread
• 00819034025565: HL 7.0mm x 70mm Short Thread
• 00819034025558: HL 7.0mm x 65mm Short Thread
• 00819034025541: HL 7.0mm x 60mm Short Thread
• 00819034025534: HL 7.0mm x 55mm Short Thread
• 00819034025527: HL 7.0mm x 50mm Short Thread
• 00819034025510: HL 7.0mm x 45mm Short Thread
• 00819034025503: HL 7.0mm x 40mm Short Thread
• 00819034025497: HL 7.0mm x 35mm Short Thread
• 00819034025480: HL 7.0mm x 30mm Short Thread
• 00819034025190: HL 5.5mm x 70mm
• 00819034025183: HL 5.5mm x 65mm
• 00819034025176: HL 5.5mm x 60mm
• 00819034025169: HL 5.5mm x 55mm
• 00819034025152: HL 5.5mm x 50mm
• 00819034025145: HL 5.5mm x 42mm
• 00819034025138: HL 5.5mm x 40mm
• 00819034025121: HL 5.5mm x 38mm
• 00819034025114: HL 5.5mm x 36mm
• 00819034025091: HL 5.5mm x 32mm
• 00819034025084: HL 5.5mm x 30mm
• 00819034025077: HL 5.5mm x 28mm