Axi+Line Bunion Correction System

GUDID 00817701020646

3.5mm Cortical Screw - 20mm

NEXTREMITY SOLUTIONS, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00817701020646
• NIH Device Record Key: 515068d1-d584-43fc-b6e3-b98487f12431
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axi+Line Bunion Correction System
• Version Model Number: SCR-3520NL
• Company DUNS: 060783407
• Company Name: NEXTREMITY SOLUTIONS, INC.
• 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	00817701020646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152548

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-31

On-Brand Devices [Axi+Line Bunion Correction System]

• 00817701020806: 3.5 mm Locking Screw - 30 mm Length
• 00817701020790: 3.5mm Locking Screw - 28mm
• 00817701020783: 3.5 mm Locking Screw - 26 mm Length
• 00817701020776: 3.5mm Locking Screw - 24mm
• 00817701020769: 3.5mm Locking Screw - 22mm
• 00817701020752: 3.5mm Locking Screw - 20mm
• 00817701020745: 3.5mm Locking Screw - 18mm
• 00817701020738: 3.5mm Locking Screw - 16mm
• 00817701020721: 3.5mm Locking Screw - 14mm
• 00817701020714: 3.5mm Locking Screw - 12mm
• 00817701020707: 3.5mm Locking Screw - 10mm
• 00817701020691: 3.5mm Cortical Screw - 30mm
• 00817701020684: 3.5mm Cortical Screw - 28mm
• 00817701020677: 3.5mm Cortical Screw - 26mm
• 00817701020660: 3.5mm Cortical Screw - 24mm
• 00817701020653: 3.5mm Cortical Screw - 22mm
• 00817701020646: 3.5mm Cortical Screw - 20mm
• 00817701020639: 3.5mm Cortical Screw - 18mm
• 00817701020622: 3.5mm Cortical Screw - 16mm
• 00817701020615: 3.5mm Cortical Screw - 14mm
• 00817701020608: 3.5mm Cortical Screw - 12mm
• 00817701020592: 3.5mm Cortical Screw - 10mm
• 00817701020585: Axi+Line Plate 12.5 Degree - Right
• 00817701020578: Axi+Line Plate 10.0 Degree - Right
• 00817701020561: Axi+Line Plate 7.5 Degree - Right
• 00817701020554: Axi+Line Plate 5.0 Degree - Right
• 00817701020547: Axi+Line Plate 12.5 Degree - Left
• 00817701020530: Axi+Line Plate 10.0 Degree - Left
• 00817701020523: Axi+Line Plate 7.5 Degree - Left
• 00817701020516: Axi+Line Plate 5.0 Degree - Left
• 00817701020509: Axi+Line Instrument Kit - Right
• 00817701020493: Axi+Line Instrument Kit - Left
• 00817701028178: Axi+Line Plate 12.5 Degree Right
• 00817701028161: Axi+Line Plate 12.5 Degree Left
• 00817701028154: Axi+Line Plate 10.0 Degree Right
• 00817701028147: Axi-Line Plate 10.0 Degree Left
• 00817701028130: Axi+Line Plate 7.5 Degree Right
• 00817701028123: Axi+Line Plate 7.5 Degree Left
• 00817701028116: Axi+Line Plate 5.0 Degree Right
• 00817701028109: Axi+Line Plate 5.0 Degree Left