CONSTRUX - MINI PTC

GUDID 18257200031214

15MM L X 15MM W, 10MM H, LORDOTIC IMPLANT, STERILE

ORTHOFIX INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 18257200031214
• NIH Device Record Key: 9e8706f0-6c56-44a4-8dfa-4724b6cfa378
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONSTRUX - MINI PTC
• Version Model Number: 37-5010SP
• 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	18257200031214 [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

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

Moist Heat or Steam Sterilization

[18257200031214]

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 PTC]

• 18257200132690: DOUBLE ENDED TRIAL - 15MM W X 15MM D X 12MM/13MM H, 5DEG LORDOTIC
• 18257200132676: DOUBLE ENDED TRIAL - 15MM W X 15MM D X 10MM/11MM H, 5DEG LORDOTIC
• 18257200132652: DOUBLE ENDED TRIAL - 15MM W X 15MM D X 8MM/9MM H, 5DEG LORDOTIC
• 18257200132638: DOUBLE ENDED TRIAL - 15MM W X 15MM D X 6MM/7MM H, 5DEG LORDOTIC
• 18257200132591: DOUBLE ENDED TRIAL -15MM W X 12MM D X 12MM/13MM H, 5DEG LORDOTIC
• 18257200132577: DOUBLE ENDED TRIAL -15MM W X 12MM D X 10MM/11MM H, 5DEG LORDOTIC
• 18257200132553: DOUBLE ENDED TRIAL -15MM W X 12MM D X 8MM/9MM H, 5DEG LORDOTIC
• 18257200132539: DOUBLE ENDED TRIAL -15MM W X 12MM D X 6MM/7MM H, 5DEG LORDOTIC
• 18257200132492: DOUBLE ENDED TRIAL -12MM W X 12MM D X 12MM/13MM H, 5DEG LORDOTIC
• 18257200132478: DOUBLE ENDED TRIAL -12MM W X 12MM D X 10MM/11MM H, 5DEG LORDOTIC
• 18257200132454: DOUBLE ENDED TRIAL -12MM W X 12MM D X 8MM/9MM H, 5DEG LORDOTIC
• 18257200132430: DOUBLE ENDED TRIAL -12MM W X 12MM D X 6MM/7MM H, 5DEG LORDOTIC
• 18257200132416: RASP - 15MM W X 12MM D X 14MM H, 5DEG LORDOTIC
• 18257200132409: RASP - 15MM W X 12MM D X 13MM H, 5DEG LORDOTIC
• 18257200132393: RASP - 15MM W X 12MM D X 12MM H, 5DEG LORDOTIC
• 18257200132386: RASP - 15MM W X 12MM D X 11MM H, 5DEG LORDOTIC
• 18257200132379: RASP - 15MM W X 12MM D X 10MM H, 5DEG LORDOTIC
• 18257200132362: RASP - 15MM W X 12MM D X 9MM H, 5DEG LORDOTIC
• 18257200132355: RASP - 15MM W X 12MM D X 8MM H, 5DEG LORDOTIC
• 18257200132348: RASP - 15MM W X 12MM D X 7MM H, 5DEG LORDOTIC
• 18257200132331: RASP - 15MM W X 12MM D X 6MM H, 5DEG LORDOTIC
• 18257200132317: RASP - 12MM W X 12MM D X 14MM H, 5DEG LORDOTIC
• 18257200132300: RASP - 12MM W X 12MM D X 13MM H, 5DEG LORDOTIC
• 18257200132294: RASP - 12MM W X 12MM D X 12MM H, 5DEG LORDOTIC
• 18257200132287: RASP - 12MM W X 12MM D X 11MM H, 5DEG LORDOTIC
• 18257200132270: RASP - 12MM W X 12MM D X 10MM H, 5DEG LORDOTIC
• 18257200132263: RASP - 12MM W X 12MM D X 9MM H, 5DEG LORDOTIC
• 18257200132256: RASP - 12MM W X 12MM D X 8MM H, 5DEG LORDOTIC
• 18257200132249: RASP - 12MM W X 12MM D X 7MM H, 5DEG LORDOTIC
• 18257200132232: RASP - 12MM W X 12MM D X 6MM H, 5DEG LORDOTIC
• 18257200093816: COMPLETE IMPLANT SET - CONSTRUX MINI PTC SPACER SYSTEM
• 18257200082452: 15MM X 15MM - TRIAL SIZERS WITH CADDY - COMPLETE ASSEMBLY, CONSTRUX MINI PEEK SPACER SYSTEM (37-
• 18257200031672: CADDY ASSEMBLY, 15MM X 15MM - TRIAL SIZERS - CONSTRUX MINI PEEK SPACER SYSTEM
• 18257200031658: 15MM L X 15MM W, 14 MM H, PARALLEL TRIAL
• 18257200031641: 15MM L X 15MM W, 13 MM H, PARALLEL TRIAL
• 18257200031634: 15MM L X 15MM W, 12 MM H, PARALLEL TRIAL
• 18257200031627: 15MM L X 15MM W, 11 MM H, PARALLEL TRIAL
• 18257200031610: 15MM L X 15MM W, 10 MM H, PARALLEL TRIAL
• 18257200031603: 15MM L X 15MM W, 9 MM H, PARALLEL TRIAL
• 18257200031597: 15MM L X 15MM W, 8 MM H, PARALLEL TRIAL
• 18257200031580: 15MM L X 15MM W, 7 MM H, PARALLEL TRIAL
• 18257200031573: 15MM L X 15MM W, 6 MM H, PARALLEL TRIAL
• 18257200031566: 15MM L X 15MM W, 14 MM H, LORDOTIC TRIAL
• 18257200031559: 15MM L X 15MM W, 13 MM H, LORDOTIC TRIAL
• 18257200031542: 15MM L X 15MM W, 12 MM H, LORDOTIC TRIAL
• 18257200031535: 15MM L X 15MM W, 11 MM H, LORDOTIC TRIAL
• 18257200031528: 15MM L X 15MM W, 10 MM H, LORDOTIC TRIAL
• 18257200031511: 15MM L X 15MM W, 9 MM H, LORDOTIC TRIAL
• 18257200031504: 15MM L X 15MM W, 8 MM H, LORDOTIC TRIAL
• 18257200031498: 15MM L X 15MM W, 7 MM H, LORDOTIC TRIAL