FO NX Nail System NXNC3540s

GUDID 09353903015772

3.5 x 40 mm NX Nail Implant 1/pkg USA Sterile

FIELD ORTHOPAEDICS PTY LTD

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

• Primary Device ID: 09353903015772
• NIH Device Record Key: a3ee109e-deb4-4188-86be-c689c7c56f97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FO NX Nail System
• Version Model Number: APN001316
• Catalog Number: NXNC3540s
• Company DUNS: 744008914
• Company Name: FIELD ORTHOPAEDICS PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	09353903015772 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230118

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-07
• Device Publish Date: 2023-07-28

On-Brand Devices [FO NX Nail System]

• 09353903013273: 5.0 NX Extremity System Tray and Lid 1/pkg
• 09353903013266: 4.0 NX Extremity System Tray and Lid 1/pkg
• 09353903013259: 3.5 NX Extremity System Tray and Lid 1/pkg
• 09353903013242: 3.0 NX Extremity System Tray and Lid 1/pkg
• 09353903013235: 2.5 NX Extremity System Tray and Lid 1/pkg
• 09353903013228: 2.0 NX Extremity System Tray and Lid 1/pkg
• 09353903012719: 5.0 NX Nail System Tray 1/pkg
• 09353903012702: 4.0 NX Nail System Tray 1/pkg
• 09353903012696: 3.5 NX Nail System Tray 1/pkg
• 09353903012689: 3.0 NX Nail System Tray 1/pkg
• 09353903012672: 2.5 NX Nail System Tray 1/pkg
• 09353903012665: 2.0 NX Nail System Tray 1/pkg
• 09353903012658: NX Nail System Lid 1/pkg
• 09353903012627: 1.8 Double-ended Trocar K-wire 150 mm 5/pkg
• 09353903012610: 1.6 Double-ended Trocar K-wire 150 mm 5/pkg
• 09353903012603: 1.4 Double-ended Trocar K-wire 150 mm 5/pkg
• 09353903012597: 1.2 Double-ended Trocar K-wire 150 mm 5/pkg
• 09353903012580: 1.2 Double-ended Trocar K-wire 100 mm 5/pkg
• 09353903012573: 1.0 Double-ended Trocar K-wire 150 mm 5/pkg
• 09353903012566: 1.0 Double-ended Trocar K-wire 100 mm 5/pkg
• 09353903012559: 0.8 Double-ended Trocar K-wire 100 mm 5/pkg
• 09353903012542: 0.8 Double-ended Trocar K-wire 70 mm 5/pkg
• 09353903012535: 0.6 Double-ended Trocar K-wire 70 mm 5/pkg
• 09353903009719: T8 Cannulated Torx Driver 1/pkg
• 09353903009696: T20 Cannulated Torx Driver 1/pkg
• 09353903009689: T15 Cannulated Torx Driver 1/pkg
• 09353903009672: T10 Cannulated Torx Driver 1/pkg
• 09353903009573: 5.0 NX Extremity Nail 90 mm 1/pkg
• 09353903009566: 5.0 NX Extremity Nail 80 mm 1/pkg
• 09353903009559: 5.0 NX Extremity Nail 70 mm 1/pkg
• 09353903009542: 5.0 NX Extremity Nail 60 mm 1/pkg
• 09353903009535: 5.0 NX Extremity Nail 55 mm 1/pkg
• 09353903009528: 5.0 NX Extremity Nail 50 mm 1/pkg
• 09353903009511: 5.0 NX Extremity Nail 45 mm 1/pkg
• 09353903009504: 5.0 NX Extremity Nail 40 mm 1/pkg
• 09353903009498: 4.0 NX Extremity Nail 80 mm 1/pkg
• 09353903009481: 4.0 NX Extremity Nail 70 mm 1/pkg
• 09353903009474: 4.0 NX Extremity Nail 60 mm 1/pkg
• 09353903009467: 4.0 NX Extremity Nail 55 mm 1/pkg
• 09353903009450: 4.0 NX Extremity Nail 50 mm 1/pkg
• 09353903009443: 4.0 NX Extremity Nail 45 mm 1/pkg
• 09353903009436: 4.0 NX Extremity Nail 40 mm 1/pkg
• 09353903009429: 3.5 NX Extremity Nail 70 mm 1/pkg
• 09353903009412: 3.5 NX Extremity Nail 60 mm 1/pkg
• 09353903009405: 3.5 NX Extremity Nail 55 mm 1/pkg
• 09353903009399: 3.5 NX Extremity Nail 50 mm 1/pkg
• 09353903009382: 3.5 NX Extremity Nail 45 mm 1/pkg
• 09353903009375: 3.5 NX Extremity Nail 40 mm 1/pkg
• 09353903009368: 3.0 NX Extremity Nail 70 mm 1/pkg
• 09353903009351: 3.0 NX Extremity Nail 60 mm 1/pkg