3 DEGREE

GUDID 18257200059232

TOP LOCKING PLATE ASSEMBLY, 3DEG ACPS

ORTHOFIX INC.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 18257200059232
• NIH Device Record Key: 7b96f4e8-2f43-4703-aa73-d9301da12347
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3 DEGREE
• Version Model Number: 60-4000
• 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
• 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	18257200059232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020620

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

[18257200059232]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-27
• Device Publish Date: 2019-03-19

On-Brand Devices [3 DEGREE]

• 18257200081509: 3 DEGREE (60-0002)
• 18257200059676: 96MM ACP 3DEG 96MM FOUR LEVEL
• 18257200059669: 92MM ACP 3DEG 92MM FOUR LEVEL
• 18257200059652: 90MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059645: 88MM ACP 3DEG 88MM FOUR LEVEL
• 18257200059638: 86MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059621: 84MM ACP 3DEG 84MM FOUR LEVEL
• 18257200059614: 82MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059607: 80MM ACP 3DEG 80MM FOUR LEVEL
• 18257200059591: 78MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059584: 76MM ACP 3DEG 76MM FOUR LEVEL
• 18257200059577: 74MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059560: 70MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059553: 68MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059546: 66MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059539: 64MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059522: 62MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059515: 60MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059508: 58MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059492: 56MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059485: 54MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059478: 52MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059461: 50MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059454: 48MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059447: 46MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059430: 44MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059423: 42MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059416: 40MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059409: 38MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059393: 36MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059386: 34MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059379: 32MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059362: 30MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059355: 28MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059348: 26MM ONE LEVEL CERVICAL PLATE ASSEMBLY 3DEG ACPS
• 18257200059331: 24MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059324: 22MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059317: 20MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
• 18257200059300: 120MM ACP 3DEG 120MM FOUR LEVEL
• 18257200059294: 116MM ACP 3DEG 116MM FOUR LEVEL
• 18257200059287: 112MM ACP 3DEG 112MM FOUR LEVEL
• 18257200059270: 108MM ACP 3DEG 108MM FOUR LEVEL
• 18257200059263: 104MM ACP 3DEG 104MM FOUR LEVEL
• 18257200059256: 100MM ACP 3DEG 100MM FOUR LEVEL
• 18257200059249: FIXED WASHER, 3DEG ACPS
• 18257200059232: TOP LOCKING PLATE ASSEMBLY, 3DEG ACPS
• 18257200059225: 4.4MM X 18MM PRIMARY BONE SCREW SELF DRILLING/SELF-TAPPING, 3DEG/RELIANT ACPS
• 18257200059218: 4.4MM X 16MM PRIMARY BONE SCREW SELF DRILLING/SELF-TAPPING, 3DEG/RELIANT ACPS
• 18257200059201: 4.4MM X 14MM PRIMARY BONE SCREW SELF DRILLING/SELF-TAPPING, 3DEG/RELIANT ACPS
• 18257200059195: 4.4MM X 12MM PRIMARY BONE SCREW SELF DRILLING/SELF-TAPPING, 3DEG/RELIANT ACPS