CENTURION

GUDID 18257200092888

6MM OCCIPITAL BONE SCREW, PRIMARY

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 18257200092888
• NIH Device Record Key: 0dc930b5-5b07-4521-8060-1f32f6202bf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CENTURION
• Version Model Number: 69-2006
• 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

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	18257200092888 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180025

FDA Product Code

• NKG: Orthosis, cervical pedicle screw spinal fixation

Sterilization

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

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

[18257200092888]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-20
• Device Publish Date: 2019-03-12

On-Brand Devices [CENTURION]

• 18257200135233: OCCIPITAL DRILL GUIDE
• 18257200125210: CENTURION - BOTTOM TRAY, OCCIPITAL CASE
• 18257200125203: CENTURION - TOP TRAY, OCCIPITAL CASE
• 18257200125197: CENTURION - BONE SCREW CADDY, OCCIPITAL CASE
• 18257200125180: CENTURION - BOTTOM TRAY, IIMPLANT CASE
• 18257200125173: CENTURION - TOP TRAY, IMPLANT CASE
• 18257200125159: CENTURION HOOK AND CONNECTOR CADDY, IMPLANT CASE
• 18257200125142: CENTURION SMOOTH SHANK SCREW CADDY, IMPLANT CASE
• 18257200125135: CENTURION - 4.5MM AND 5.0MM MULTI-AXIAL SCREW CADDY, IMPLANT CASE
• 18257200125128: CENTURION - 4.0MM MULTI-AXIAL SCREW CADDY, IMPLANT CASE
• 18257200125111: CENTURION - 3.5MM MULTI-AXIAL SCREW CADDY, IMPLANT CASE
• 18257200125104: CENTURION SET SCREW CADDY, IMPLANT CASE
• 18257200118786: CENTURION - IMPLANT TRAY KIT (69-9092)
• 18257200110124: CENTURION - INSTRUMENT TRAY KIT (69-9091)
• 18257200105403: OCCIPITAL COUNTER TORQUE WRENCH
• 18257200105397: OCCIPITAL TAP
• 18257200105380: OCCIPITAL DRIVER - ANGLED
• 18257200105373: OCCIPITAL DRIVER - STRAIGHT
• 18257200105366: OCCIPITAL BONE SCREW INSERTER
• 18257200105359: ANVIL OCCIPITAL PLATE BENDER
• 18257200105342: OCCIPITAL PLATE BENDER
• 18257200105335: LAMINAR ELEVATOR
• 18257200105328: OCCIPITAL DRILL
• 18257200094172: HANDLE ADAPTER
• 18257200094165: PLATE HOLDER
• 18257200094134: CENTURION - OCCIPITAL IMPLANT & INSTRUMENT CASE
• 18257200094097: ROD REDUCER
• 18257200094080: DISTRACTOR
• 18257200094073: COUNTER TORQUE WRENCH
• 18257200094066: OCCIPITAL SET SCREW DRIVER
• 18257200094059: SET SCREW DRIVER
• 18257200094042: SET SCREW INSERTER - DUAL SIDED
• 18257200094035: ROD ROCKER
• 18257200094028: COMPRESSOR
• 18257200094011: ADJUSTMENT DRIVER
• 18257200094004: ROD HOLDER
• 18257200093991: ROD BENDER
• 18257200093984: ROD CUTTER
• 18257200093977: MULTI-AXIAL SCREW DRIVER
• 18257200093960: OCCIPITAL MODULAR IN-LINE HANDLE
• 18257200093953: MODULAR IN-LINE HANDLE
• 18257200093946: MODULAR BALL HANDLE
• 18257200093939: 5.0MM TAP
• 18257200093922: 4.5MM TAP
• 18257200093915: 4.0MM TAP
• 18257200093908: 3.5MM TAP
• 18257200093892: 5.0MM DRILL BIT
• 18257200093885: 4.5MM DRILL BIT
• 18257200093878: 4.0MM DRILL BIT
• 18257200093861: 3.5MM DRILL BIT