FORZA PTC

GUDID 18257200091928

9W X 27L X 11H, 0DEG STRAIGH PTC 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: 18257200091928
• NIH Device Record Key: 45d0d7e4-b0ae-402b-8238-c6ea3560aa4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORZA PTC
• Version Model Number: 38-3011SP
• 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	18257200091928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172437

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

Moist Heat or Steam Sterilization

[18257200091928]

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: 2019-03-12

On-Brand Devices [FORZA PTC]

• 18257200111411: 11W X 27L X 11H, 0DEG STRAIGHT PTC IMPLANT, STERILE
• 18257200111404: 9W X 23L X 10H, 0DEG STRAIGHT PTC IMPLANT, STERILE
• 18257200111305: 11W X 27L X 13H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092321: 9W X 27L X 14H, 8DEG CURVED PTC IMPLANT, STERILE
• 18257200092314: 9W X 27L X 13H, 8DEG CURVED PTC IMPLANT, STERILE
• 18257200092307: 9W X 27L X 12H, 8DEG CURVED PTC IMPLANT, STERILE
• 18257200092291: 9W X 27L X 11H, 8DEG CURVED PTC IMPLANT, STERILE
• 18257200092284: 9W X 27L X 10H, 8DEG CURVED PTC IMPLANT, STERILE
• 18257200092277: 9W X 27L X 9H, 8DEG CURVED PTC IMPLANT, STERILE
• 18257200092260: 9W X 27L X 8H, 8DEG CURVED PTC IMPLANT, STERILE
• 18257200092253: 9W X 27L X 14H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092246: 9W X 27L X 13H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092239: 9W X 27L X 12H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092222: 9W X 27L X 11H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092215: 9W X 27L X 10H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092208: 9W X 27L X 9H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092192: 9W X 27L X 8H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092185: 9W X 27L X 7H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092178: 11W X 31L X 14H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092161: 11W X 31L X 13H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092154: 11W X 31L X 12H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092147: 11W X 31L X 11H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092130: 11W X 31L X 10H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092123: 11W X 31L X 9H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092116: 11W X 31L X 8H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092109: 11W X 31L X 7H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092093: 11W X 27L X 14H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092079: 11W X 27L X 12H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092062: 11W X 27L X 11H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092055: 11W X 27L X 10H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092048: 11W X 27L X 9H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092031: 11W X 27L X 8H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092024: 11W X 27L X 7H, 0DEG CURVED PTC IMPLANT, STERILE
• 18257200092017: 9W X 27L X 14H, 8DEG STRAIGHT PTC IMPLANT, STERILE
• 18257200092000: 9W X 27L X 13H, 8DEG STRAIGHT PTC IMPLANT, STERILE
• 18257200091997: 9W X 27L X 12H, 8DEG STRAIGHT PTC IMPLANT, STERILE
• 18257200091980: 9W X 27L X 11H, 8DEG STRAIGHT PTC IMPLANT, STERILE
• 18257200091973: 9W X 27L X 10H, 8DEG STRAIGHT PTC IMPLANT, STERILE
• 18257200091966: 9W X 27L X 9H, 8DEG STRAIGHT PTC IMPLANT, STERILE
• 18257200091959: 9W X 27L X 14H, 0DEG STRAIGH PTC IMPLANT, STERILE
• 18257200091942: 9W X 27L X 13H, 0DEG STRAIGH PTC IMPLANT, STERILE
• 18257200091935: 9W X 27L X 12H, 0DEG STRAIGH PTC IMPLANT, STERILE
• 18257200091928: 9W X 27L X 11H, 0DEG STRAIGH PTC IMPLANT, STERILE
• 18257200091911: 9W X 27L X 10H, 0DEG STRAIGH PTC IMPLANT, STERILE
• 18257200091904: 9W X 27L X 9H, 0DEG STRAIGHT PTC IMPLANT, STERILE
• 18257200091898: 9W X 27L X 8H, 0DEG STRAIGHT PTC IMPLANT, STERILE
• 18257200091881: 9W X 27L X 7H, 0DEG STRAIGHT PTC IMPLANT, STERILE
• 18257200091874: 11W X 31L X 14H, 0DEG STRAIGHT PTC IMPLANT, STERILE
• 18257200091867: 11W X 31L X 13H, 0DEG STRAIGHT PTC IMPLANT, STERILE
• 18257200091850: 11W X 31L X 12H, 0DEG STRAIGHT PTC IMPLANT, STERILE