ASCENT

GUDID 18257200063611

3.5MM X 18MM MULTI-AXIAL SCREW, ASCENT POCT

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: 18257200063611
• NIH Device Record Key: 0ec0f5f9-e5a5-405b-a162-771db3651090
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASCENT
• Version Model Number: 65-3318
• 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	18257200063611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111183

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

Moist Heat or Steam Sterilization

[18257200063611]

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 [ASCENT]

• 18257200081578: ASCENT POCTS CASE 3, SONGER CABLE SET (65-0100)
• 18257200081561: ASCENT POCTS CASE 2 (65-0020)
• 18257200081554: ASCENT POCTS CASE 1 (65-0010)
• 18257200064731: LAMINAR ELEVATOR, POCTS
• 18257200063796: 4.0MM X 30MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063789: 4.0MM X 28MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063772: 4.0MM X 26MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063765: 4.0MM X 24MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063758: 4.0MM X 22MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063741: 4.0MM X 20MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063734: 4.0MM X 18MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063727: 4.0MM X 16MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063710: 4.0MM X 14MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063703: 4.0MM X 12MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063697: 4.0MM X 10MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063680: ASCENT POCTS 4.0MM POLY- AXIAL SCREW ASSY 9.4MM
• 18257200063673: 3.5MM X 30MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063666: 3.5MM X 28MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063659: 3.5MM X 26MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063642: 3.5MM X 24MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063635: 3.5MM X 22MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063628: 3.5MM X 20MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063611: 3.5MM X 18MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063604: 3.5MM X 16MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063598: 3.5MM X 14MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063581: 3.5MM X 12MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063574: 3.5MM X 10MM MULTI-AXIAL SCREW, ASCENT POCT
• 18257200063567: ASCENT POCTS 3.5MM POLY- AXIAL SCREW ASSY 9.4MM
• 18257200063550: PRE-BENT OCCIPITAL ROD, ASCENT POCT
• 18257200063543: 50MM OCCIPITAL ANCHOR PLATE, ASCENT POCT
• 18257200063536: 45MM OCCIPITAL ANCHOR PLATE, ASCENT POCT
• 18257200063529: 37MM OCCIPITAL ANCHOR PLATE, ASCENT POCT
• 18257200063512: 31MM OCCIPITAL ANCHOR PLATE, ASCENT POCT
• 18257200063505: ASCENT POCTS SET SCREW
• 18257200063482: ASCENT POCTS CABLE SYSTEM, INSTRUMENT CASE #3
• 18257200063475: ASCENT POCTS INSTRUMENT CASE2 CASE #2
• 18257200063468: ASCENT POCTS INSTRUMENT CASE1 CASE #1
• 18257200063451: CROSS CONNECTOR TEMPLATE 45MM-50MM, ASCENT LE/ASCENT POCT
• 18257200063444: CROSS CONNECTOR TEMPLATE 35MM-40MM, ASCENT LE/ASCENT POCT
• 18257200063437: CROSS CONNECTOR TEMPLATE 25MM-30MM, ASCENT LE/ASCENT POCT
• 18257200063420: CROSS CONNECTOR TEMPLATE 20MM, ASCENT LE/ASCENT POCT
• 18257200063383: CABLE TORQUE DRIVER, ASCENT POCT
• 18257200063376: CABLE CUTTER, ASCENT POCT
• 18257200063369: CRIMP INSERTER, ASCENT POCT
• 18257200063352: ROD REDUCER, ASCENT POCT
• 18257200063345: DISTRACTOR, ASCENT POCT
• 18257200063338: TENSIONER AND CRIMPER, ASCENT POCT
• 18257200063321: COUNTER TORQUE WRENCH, ASCENT LE/ASCENT POCT
• 18257200063314: TORQUE LIMITING DRIVER, T-HANDLE, ASCENT LE/ASCENT POCT
• 18257200063307: DOMED SET SCREW DRIVER, ASCENT POCT