CONSTRUX - MINI PEEK VBR

GUDID 18257200042029

CONSTRUX MINI 7MM H X 12MM W X 12MM L - PARALLEL

ORTHOFIX INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 18257200042029
• NIH Device Record Key: 2a0105c8-3b5c-4409-9215-6d99bd2ec952
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONSTRUX - MINI PEEK VBR
• Version Model Number: 47-3107
• Company DUNS: 927083808
• Company Name: ORTHOFIX 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200042029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172437

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

[18257200042029]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-03-19

On-Brand Devices [CONSTRUX - MINI PEEK VBR]

• 18257200135813: IMPLANT INSERTER ASSEMBLY
• 18257200082957: CONSTRUX MINI PEEK SPACER SYSTEM - INSTRUMENT KIT (47-0012)
• 18257200081370: CONSTRUX MINI, SPACER AND VBR SYSTEMS (47-0010)
• 18257200042357: CONSTRUX MINI 15MM W X 12MM D X 14MM H, PARALLEL
• 18257200042340: CONSTRUX MINI 14MM H X 15MM W X 12MM L - PARALLEL
• 18257200042333: CONSTRUX MINI 15MM W X 12MM D X 13MM H, PARALLEL
• 18257200042326: CONSTRUX MINI 13MM H X 15MM W X 12MM L - PARALLEL
• 18257200042319: CONSTRUX MINI 12MM H X 15MM W X 12MM L - PARALLEL
• 18257200042302: CONSTRUX MINI 11MM H X 15MM W X 12MM L - PARALLEL
• 18257200042296: CONSTRUX MINI 10MM H X 15MM W X 12MM L - PARALLEL
• 18257200042289: CONSTRUX MINI 9MM H X 15MM W X 12MM L - PARALLEL
• 18257200042272: CONSTRUX MINI 8MM H X 15MM W X 12MM L - PARALLEL
• 18257200042265: CONSTRUX MINI 7MM H X 15MM W X 12MM L - PARALLEL
• 18257200042258: CONSTRUX MINI 6MM H X 15MM W X 12MM L - PARALLEL
• 18257200042241: CONSTRUX MINI 5MM H X 15MM W X 12MM L - PARALLEL
• 18257200042234: CONSTRUX MINI 15MM W X 12MM D X 14MM H, 5? LORDOTIC
• 18257200042227: CONSTRUX MINI 14MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042210: CONSTRUX MINI 15MM W X 12MM D X 13MM H, 5? LORDOTIC
• 18257200042203: CONSTRUX MINI 13MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042197: CONSTRUX MINI 12MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042180: CONSTRUX MINI 11MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042173: CONSTRUX MINI 10MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042166: CONSTRUX MINI 9MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042159: CONSTRUX MINI 8MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042142: CONSTRUX MINI 7MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042135: CONSTRUX MINI 6MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042128: CONSTRUX MINI 5MM H X 15MM W X 12MM L - 5DEG LORDOTIC
• 18257200042111: CONSTRUX MINI 12MM W X 12MM D X 14MM H, PARALLEL
• 18257200042104: CONSTRUX MINI 14MM H X 12MM W X 12MM L - PARALLEL
• 18257200042098: CONSTRUX MINI 12MM W X 12MM D X 13MM H, PARALLEL
• 18257200042081: CONSTRUX MINI 13MM H X 12MM W X 12MM L - PARALLEL
• 18257200042074: CONSTRUX MINI 12MM H X 12MM W X 12MM L - PARALLEL
• 18257200042067: CONSTRUX MINI 11MM H X 12MM W X 12MM L - PARALLEL
• 18257200042050: CONSTRUX MINI 10MM H X 12MM W X 12MM L - PARALLEL
• 18257200042043: CONSTRUX MINI 9MM H X 12MM W X 12MM L - PARALLEL
• 18257200042036: CONSTRUX MINI 8MM H X 12MM W X 12MM L - PARALLEL
• 18257200042029: CONSTRUX MINI 7MM H X 12MM W X 12MM L - PARALLEL
• 18257200042012: CONSTRUX MINI 6MM H X 12MM W X 12MM L - PARALLEL
• 18257200042005: CONSTRUX MINI 5MM H X 12MM W X 12MM L - PARALLEL
• 18257200041992: CONSTRUX MINI 12MM W X 12MM D X 14MM H, 5? LORDOTIC
• 18257200041985: CONSTRUX MINI 14MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041978: CONSTRUX MINI 12MM W X 12MM D X 13MM H, 5? LORDOTIC
• 18257200041961: CONSTRUX MINI 13MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041954: CONSTRUX MINI 12MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041947: CONSTRUX MINI 11MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041930: CONSTRUX MINI 10MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041923: CONSTRUX MINI 9MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041916: CONSTRUX MINI 8MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041909: CONSTRUX MINI 7MM H X 12MM W X 12MM L - 5DEG LORDOTIC
• 18257200041893: CONSTRUX MINI 6MM H X 12MM W X 12MM L - 5DEG LORDOTIC