PILLAR PL

GUDID 18257200039555

PILLAR PL SPACER 11X27X15, 8DEG LORDOTIC

ORTHOFIX INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 18257200039555
• NIH Device Record Key: 0f083628-3ec2-496d-99a4-f1d93ac63d42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PILLAR PL
• Version Model Number: 45-6515
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200039555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082235

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

[18257200039555]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-03-19

On-Brand Devices [PILLAR PL]

• 18257200081301: PILLAR PL PEEK PARTIAL VBR SYSTEM, IMPLANT/INSTRUMENT CASE (45-0014)
• 18257200081288: PILLAR PL VBR SYSTEM, 11MM X 27MM IMPLANTS AND TRIALS (46-0010)
• 18257200081264: PILLAR PL (45-9097)
• 18257200041312: FERRIS-SMITH RONGUERS: 4.0 X 10MM UP-ANGLE
• 18257200041305: FERRIS-SMITH RONGUERS: 4.0 X 10MM STRAIGHT
• 18257200041299: FERRIS-SMITH RONGUERS: 2.5 X 10MM STRAIGHT
• 18257200041282: PILLAR PL TRIAL 11X33X16 PARALLEL
• 18257200041275: PILLAR PL TRIAL 11X33X15 PARALLEL
• 18257200041268: PILLAR PL TRIAL 11X33X14 PARALLEL
• 18257200041251: PILLAR PL TRIAL 11X33X13 PARALLEL
• 18257200041244: PILLAR PL TRIAL 11X33X12 PARALLEL
• 18257200041237: PILLAR PL TRIAL 11X33X11 PARALLEL
• 18257200041220: PILLAR PL TRIAL 11X33X10 PARALLEL
• 18257200041213: PILLAR PL TRIAL 11X33X9 PARALLEL
• 18257200041206: PILLAR PL TRIAL 11X33X8 PARALLEL
• 18257200041190: PILLAR PL TRIAL 11X33X7 PARALLEL
• 18257200041183: PILLAR PL TRIAL 11X33X6 PARALLEL
• 18257200041176: SYPERT LARGE RONGUERS
• 18257200041169: SYPERT SMALL RONGUERS
• 18257200041152: PILLAR PL TRIAL 11X27X16, 8DEG LORDOTIC
• 18257200041145: PILLAR PL TRIAL 11X27X15, 8DEG LORDOTIC
• 18257200041138: PILLAR PL TRIAL 11X27X14, 8DEG LORDOTIC
• 18257200041121: PILLAR PL TRIAL 11X27X13, 8DEG LORDOTIC
• 18257200041114: PILLAR PL TRIAL 11X27X12, 8DEG LORDOTIC
• 18257200041107: PILLAR PL TRIAL 11X27X11, 8DEG LORDOTIC
• 18257200041091: PILLAR PL TRIAL 11X27X10, 8DEG LORDOTIC
• 18257200041084: PILLAR PL TRIAL 11X27X9, 8DEG LORDOTIC
• 18257200041077: PILLAR PL TRIAL 11X27X8, 8DEG LORDOTIC
• 18257200041060: PILLAR PL TRIAL 11X27X7, 8DEG LORDOTIC
• 18257200041053: PILLAR PL TRIAL 11X27X6, 8DEG LORDOTIC
• 18257200041046: WIDE CHISEL
• 18257200041039: NARROW CHISEL
• 18257200041022: PILLAR PL TRIAL 11X27X16 PARALLEL
• 18257200041015: PILLAR PL TRIAL 11X27X15 PARALLEL
• 18257200041008: PILLAR PL TRIAL 11X27X14 PARALLEL
• 18257200040995: PILLAR PL TRIAL 11X27X13 PARALLEL
• 18257200040988: PILLAR PL TRIAL 11X27X12 PARALLEL
• 18257200040971: PILLAR PL TRIAL 11X27X11 PARALLEL
• 18257200040964: PILLAR PL TRIAL 11X27X10 PARALLEL
• 18257200040957: PILLAR PL TRIAL 11X27X9 PARALLEL
• 18257200040940: PILLAR PL TRIAL 11X27X8 PARALLEL
• 18257200040933: PILLAR PL TRIAL 11X27X7 PARALLEL
• 18257200040926: PILLAR PL TRIAL 11X27X6 PARALLEL
• 18257200040483: PILLAR PL TRIAL 9X23X16, 8DEG LORDOTIC
• 18257200040476: PILLAR PL TRIAL 9X23X15, 8DEG LORDOTIC
• 18257200040469: PILLAR PL TRIAL 9X23X14, 8DEG LORDOTIC
• 18257200040452: PILLAR PL TRIAL 9X23X13, 8DEG LORDOTIC
• 18257200040445: PILLAR PL TRIAL 9X23X12, 8DEG LORDOTIC
• 18257200040438: PILLAR PL TRIAL 9X23X11, 8DEG LORDOTIC
• 18257200040421: PILLAR PL TRIAL 9X23X10, 8DEG LORDOTIC