ASCENT LE

GUDID 18257200018819

70MM X 3.0MM COCR STRAIGHT ROD

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 18257200018819
• NIH Device Record Key: 076bf7c5-f8a5-4a83-9a2b-33404c2ba086
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASCENT LE
• Version Model Number: 66-2070
• 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	18257200018819 [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

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

Moist Heat or Steam Sterilization

[18257200018819]

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 LE]

• 18257200125166: LID, ASCENT LE CASE
• 18257200082056: EVOLUTION, REMOVAL KIT, THORACOLUMBAR SPINE HARDWARE (ES-0005)
• 18257200081998: ASCENT LE ML BIAS ANGLE SCREWS (66-0023)
• 18257200081981: ASCENT LE CC BIAS ANGLE SCREWS (66-0024)
• 18257200081974: ASCENT LE SMOOTH SHANK SCREWS (66-0022)
• 18257200081967: ASCENT LE MULTI-AXIAL SCREWS (66-0021)
• 18257200081615: ASCENT LE AUX (66-0030)
• 18257200081608: ASCENT LE IMPLANTS (66-0020)
• 18257200081592: ASCENT LE INST 2 (66-0011)
• 18257200081585: ASCENT LE INST 1 (66-0010)
• 18257200064700: 4.0MM X 52MM C-C BIASED ANGLE RESCUE SCREW ASSY
• 18257200064694: 4.0MM X 50MM C-C BIASED ANGLE RESCUE SCREW ASSY
• 18257200064687: 4.0MM X 48MM C-C BIASED ANGLE RESCUE SCREW ASSY
• 18257200064670: 4.0MM X 46MM C-C BIASED ANGLE RESCUE SCREW ASSY
• 18257200064663: 4.0MM X 44MM C-C BIASED ANGLE RESCUE SCREW ASSY
• 18257200064656: 4.0MM X 36MM C-C BIASED ANGLE SCREW, ASCENT LE POCT
• 18257200064649: 3.5MM X 52MM C-C BIASED ANGLE SCREW ASSY
• 18257200064632: 3.5MM X 50MM C-C BIASED ANGLE SCREW ASSY
• 18257200064625: 3.5MM X 48MM C-C BIASED ANGLE SCREW ASSY
• 18257200064618: 3.5MM X 46MM C-C BIASED ANGLE SCREW ASSY
• 18257200064601: 3.5MM X 44MM C-C BIASED ANGLE SCREW ASSY
• 18257200064595: 3.5MM X 42MM C-C BIASED ANGLE SCREW ASSY
• 18257200064588: 4.0MM X 52MM M-L BIASED ANGLE RESCUE SCREW ASSY
• 18257200064571: 4.0MM X 50MM M-L BIASED ANGLE RESCUE SCREW ASSY
• 18257200064564: 4.0MM X 48MM M-L BIASED ANGLE RESCUE SCREW ASSY
• 18257200064557: 4.0MM X 46MM M-L BIASED ANGLE RESCUE SCREW ASSY
• 18257200064540: 4.0MM X 44MM M-L BIASED ANGLE RESCUE SCREW ASSY
• 18257200064533: 3.5MM X 52MM M-L BIASED ANGLE SCREW
• 18257200064526: 3.5MM X 50MM M-L BIASED ANGLE SCREW
• 18257200064519: 3.5MM X 48MM M-L BIASED ANGLE SCREW
• 18257200064502: 3.5MM X 46MM M-L BIASED ANGLE SCREW
• 18257200064496: 3.5MM X 44MM M-L BIASED ANGLE SCREW
• 18257200064489: 3.5MM X 42MM M-L BIASED ANGLE SCREW
• 18257200064472: 4.0MM X 52MM MULTI-AXIAL SCREW ASSY
• 18257200064465: 4.0MM X 50MM MULTI-AXIAL SCREW ASSY
• 18257200064458: 4.0MM X 48MM MULTI-AXIAL SCREW ASSY
• 18257200064441: 4.0MM X 46MM MULTI-AXIAL SCREW ASSY
• 18257200064434: 4.0MM X 44MM MULTI-AXIAL SCREW ASSY
• 18257200064427: 4.0MM X 36MM MULTI-AXIAL SCREW, ASCENT LE POCT
• 18257200064410: 3.5MM X 52MM MULTI-AXIAL SCREW ASSY
• 18257200064403: 3.5MM X 50MM MULTI-AXIAL SCREW ASSY
• 18257200064397: 3.5MM X 48MM MULTI-AXIAL SCREW ASSY
• 18257200064380: 3.5MM X 46MM MULTI-AXIAL SCREW ASSY
• 18257200064373: 3.5MM X 44MM MULTI-AXIAL SCREW ASSY
• 18257200064366: 3.5MM X 42MM MULTI-AXIAL SCREW ASSY
• 18257200064359: 4.0MM X 52MM SMOOTH SHANK SCREW ASSY
• 18257200064342: 4.0MM X 50MM SMOOTH SHANK SCREW ASSY
• 18257200064335: 4.0MM X 48MM SMOOTH SHANK SCREW ASSY
• 18257200064328: 4.0MM X 46MM SMOOTH SHANK SCREW ASSY
• 18257200064311: 4.0MM X 44MM SMOOTH SHANK SCREW ASSY