FuzeFix Large TN-FX-7028

GUDID 00819034027330

FX Wire Sleeve 7.0mm

FUSION ORTHOPEDICS, LLC

Orthopaedic implantation sleeve, single-use

• Primary Device ID: 00819034027330
• NIH Device Record Key: 45df1f57-0dc9-40bc-8da5-c0c6f6123909
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix Large
• Version Model Number: TN-FX-7028
• Catalog Number: TN-FX-7028
• 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	00819034027330 [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

[00819034027330]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-30
• Device Publish Date: 2019-04-22

On-Brand Devices [FuzeFix Large]

• 00819034028320: Headless Screw HL 5.5mm x 45mm
• 00819034028313: Cannulated Screw HD 5.5mm x 45mm
• 00819034027330: FX Wire Sleeve 7.0mm
• 00819034027323: FX Drill Sleeve 7.0mm
• 00819034027316: FX Sleeve 5.5mm and 7.0mm
• 00819034027309: FX Drill Sleeve 5.5mm
• 00819034027293: FX Wire Sleeve 5.5mm
• 00819034027286: Parallel Wire Guide HD 5.5mm
• 00819034027279: Parallel Wire Guide HD 7.0mm
• 00819034027262: Parallel Wire Guide HL 7.0mm
• 00819034026883: Depth Gauge HL 5.5mm/7.0mm
• 00819034026876: Depth Gauge HD 5.5mm/7.0mm
• 00819034026203: Screw Holding Forceps Large
• 00819034026180: 7.0mm Guide 4.9mm and 2.8mm
• 00819034026173: 5.5mm Guide 3.6mm and 2.0mm
• 00819034025824: Screw Extractor Rod 7.0mm
• 00819034025817: Screw Extractor Rod 5.5mm
• 00819034025749: Driver Torx 7.0mm
• 00819034025732: Driver Torx 5.5mm
• 00819034025725: Proximal Reamer Cannulated 7.0mm
• 00819034025718: Proximal Reamer Cannulated 5.5mm
• 00819034025107: K-Wire Threaded 2.0mm
• 00819034025022: K-Wire Standard 2.0mm
• 00819034025015: Tap Cannulated 7.0mm
• 00819034025008: Tap Cannulated 5.5mm
• 00819034024964: Driver Torx Removal 7.0mm
• 00819034024957: Driver Torx Removal 5.5mm
• 00819034024940: K-Wire Threaded 2.8mm
• 00819034024933: K-Wire Threaded 1.6mm
• 00819034024926: K-Wire Standard 2.8mm
• 00819034024919: K-Wire Standard 1.6mm
• 00819034024865: Proximal Reamer Headless 7.0mm
• 00819034024858: Proximal Reamer Headless 5.5mm
• 00819034024834: Calibrated Drill Cannulated 4.9mm
• 00819034024827: Calibrated Drill Cannulated 3.6mm
• 00819034029686: FX Parallel Wire Guide HL 5.5mm
• 00840124502253: HD FT 5.5mm x 90mm
• 00840124502239: HD FT 5.5mm x 80mm
• 00840124502222: HD FT 5.5mm x 75mm
• 00840124502215: HD FT 5.5mm x 70mm
• 00840124502208: HD FT 5.5mm x 65mm
• 00840124502192: HD FT 5.5mm x 60mm
• 00840124502185: HD FT 5.5mm x 55mm
• 00840124502178: HD FT 5.5mm x 50mm
• 00840124502161: HD FT 5.5mm x 48mm
• 00840124502154: HD FT 5.5mm x 46mm
• 00840124502147: HD FT 5.5mm x 45mm
• 00840124502130: HD FT 5.5mm x 44mm
• 00840124502123: HD FT 5.5mm x 42mm
• 00840124502116: HD FT 5.5mm x 40mm