Firebired

GUDID 18257200113163

10.5MM X 25MM MODULAR BONE SCREW, SELF-TAPPING

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 18257200113163
• NIH Device Record Key: 10f1308e-fb7a-4d4f-a427-61251fb4aa6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Firebired
• Version Model Number: 44-5025 AF
• Company DUNS: 927083808
• Company Name: ORTHOFIX INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200113163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171082

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

[18257200113163]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-21

Devices Manufactured by ORTHOFIX INC.

• 18257200068166 - PILLAR XL: 2020-02-24 PARALLEL RASP TRIAL - 18XXXX9MM
• 18257200081387 - CONSTRUX - PEEK VBR: 2020-02-24 PILLAR AL (48-0010)
• 18257200131969 - PEMF - PHYSIO-STIM: 2020-02-24 5302, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
• 18257200131976 - PEMF - PHYSIO-STIM: 2020-02-24 5303, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
• 18257200131983 - PEMF - PHYSIO-STIM: 2020-02-24 5313, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
• 18257200131990 - PEMF - PHYSIO-STIM: 2020-02-24 5314L, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
• 18257200132003 - PEMF - PHYSIO-STIM: 2020-02-24 5314R, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
• 18257200132010 - PEMF - PHYSIO-STIM: 2020-02-24 5315, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US