FORZA

GUDID 18257200022991

9W X 23L X 11H, 4DEG STRAIGHT IMPLANT, STERILE

ORTHOFIX INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 18257200022991
• NIH Device Record Key: 21119c55-9692-4601-8025-b2474456240a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORZA
• Version Model Number: 87-7011SP
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200022991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162446

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

Moist Heat or Steam Sterilization

[18257200022991]

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: 2019-09-24

On-Brand Devices [FORZA]

• 18257200111374: FORZA - 11X31 - CURVED - STERILE IMPLANT SHIPPING TOTE - CONFIGURATION 9 (FOZ9-0002)
• 18257200111367: FORZA - 11X27 - CURVED - STERILE IMPLANT SHIPPING TOTE - CONFIGURATION 8 (FOZ8-0002)
• 18257200111350: FORZA - 9X27 - CURVED - STERILE IMPLANT SHIPPING TOTE - CONFIGURATION 7 (FOZ7-0002)
• 18257200111343: FORZA - 9X27 - STRAIGHT - STERILE IMPLANT SHIPPING TOTE - CONFIGURATION 5 (FOZ5-0002)
• 18257200111336: FORZA - 11X31 - STRAIGHT - STERILE IMPLANT SHIPPING TOTE - CONFIGURATION 4 (FOZ4-0002)
• 18257200111329: FORZA - 11X27 - STRAIGHT - STERILE IMPLANT SHIPPING TOTE - CONFIGURATION 3 (FOZ3-0002)
• 18257200111312: FORZA - 9X23 - STRAIGHT - STERILE IMPLANT SHIPPING TOTE - CONFIGURATION 1 (FOZ1-0002)
• 18257200106189: 11MM ARTICULATING TAMP
• 18257200106165: 9MM ARTICULATING TAMP
• 18257200082377: FORZA - DISCECTOMY TRAY (89-0031)
• 18257200082360: FORZA - TRIAL TRAY (89-0022)
• 18257200082353: FORZA - INSTRUMENT TRAY (89-0021)
• 18257200078301: 9W X 27L X 7H, 0DEG CURVED TRIAL
• 18257200078295: 9W X 27L X 6H, 0DEG CURVED TRIAL
• 18257200078288: PITUITARY, UP, 4MM
• 18257200078271: PITUITARY, STRAIGHT, 4MM
• 18257200078264: PITUITARY, UP, 2MM
• 18257200078257: PITUITARY, STRAIGHT, 2MM
• 18257200078240: MALLEABLE NERVE ROOT RETRACTOR
• 18257200078233: NERVE ROOT RETRACTOR
• 18257200078226: NERVE ROOT RETRACTOR
• 18257200078219: 11MM MONOLITHIC STRAIGHT IMPLANT INSERTER
• 18257200078202: 9MM MONOLITHIC STRAIGHT IMPLANT INSERTER
• 18257200078196: BONE PACKING TOOL
• 18257200078189: 16MM ROTATING CUTTER
• 18257200078172: 15MM ROTATING CUTTER
• 18257200078165: 14MM ROTATING CUTTER
• 18257200078158: 13MM ROTATING CUTTER
• 18257200078141: 12MM ROTATING CUTTER
• 18257200078134: 11MM ROTATING CUTTER
• 18257200078127: 10MM ROTATING CUTTER
• 18257200078110: 9MM ROTATING CUTTER
• 18257200078103: 8MM ROTATING CUTTER
• 18257200078097: 7MM ROTATING CUTTER
• 18257200078080: 6MM ROTATING CUTTER
• 18257200078073: ROTATING CUTTER - 16MM
• 18257200078066: ROTATING CUTTER - 15MM
• 18257200078059: ROTATING CUTTER - 14MM
• 18257200078042: ROTATING CUTTER - 13MM
• 18257200078035: ROTATING CUTTER - 12MM
• 18257200078028: ROTATING CUTTER - 11MM
• 18257200078011: ROTATING CUTTER - 10MM
• 18257200078004: ROTATING CUTTER - 9MM
• 18257200077991: ROTATING CUTTER - 8MM
• 18257200077984: ROTATING CUTTER - 7MM
• 18257200077977: ROTATING CUTTER - 6MM
• 18257200077960: CURVED CHISEL
• 18257200077953: FLAT CHISEL
• 18257200077946: RING CURETTE - LARGE
• 18257200077939: RING CURETTE - SMALL