HALLMARK

GUDID 18257200018390

86MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS

ORTHOFIX INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 18257200018390
• NIH Device Record Key: 1ae15fe6-79af-419a-a77b-76a26611df12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HALLMARK
• Version Model Number: 62-6860
• 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	18257200018390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100614

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

Moist Heat or Steam Sterilization

[18257200018390]

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 [HALLMARK]

• 18257200081523: HALLMARK (62-9020)
• 18257200081516: HALLMARK (62-9001)
• 18257200062249: SEQUENCE ADJUSTABLE MODULAR BONE DRILL
• 18257200062171: 4 LEVEL PLATE TRAY HALLMARK ACPS
• 18257200062164: INSTRUMENT CASE HALLMARK ACPS
• 18257200062157: PLATE BENDER HALLMARK ACPS
• 18257200062133: TOP LOCKING PLATE SCREW DRIVER HOLDER HALLMARK ACPS
• 18257200062126: TORQUE LIMITING HANDLE, 1/4 SQ QUICK LOCK HALLMARK ACPS
• 18257200062119: TOP LOCKING PLATE SCREW DRIVER HALLMARK ACPS
• 18257200062102: BONE SCREW DRIVER/HOLDER HALLMARK ACPS
• 18257200062089: SLEEVED BONE AWL ASSEMBLY HALLMARK ACPS
• 18257200062072: MODULAR BONE AWL HALLMARK ACPS
• 18257200062065: TACK HOLDER ASSY HALLMARK ACPS
• 18257200062058: DRILL GUIDE HALLMARK ACPS
• 18257200018468: 98MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018451: 95MM FIVE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018444: 94MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018437: 90MM FIVE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018420: 90MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018413: 90MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018406: 86MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018390: 86MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018383: 85MM FIVE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018376: 82MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018369: 82MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018352: 80MM FIVE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018345: 78MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018338: 78MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018321: 74MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018314: 74MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018307: 72MM FOUR LEVEL CERVICAL PLATE ASSEMBLY
• 18257200018291: 70MM FOUR LEVEL CERVICAL PLATE ASSEMBLY
• 18257200018284: 70MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018277: 68MM FOUR LEVEL CERVICAL PLATE ASSEMBLY
• 18257200018260: 68MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018253: 66MM FOUR LEVEL CERVICAL PLATE ASSEMBLY
• 18257200018246: 66MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
• 18257200018239: 64MM FOUR LEVEL CERVICAL PLATE ASSEMBLY
• 18257200018222: 64mm Three Level Cervical Plate
• 18257200018215: 62mm Four Level Cervical Plate
• 18257200018208: 62mm Three Level Cervical Plate
• 18257200018192: 60mm Three Level Cervical Plate
• 18257200018185: 58mm Three Level Cervical Plate
• 18257200018178: 56mm Three Level Cervical Plate
• 18257200018161: 54mm Three Level Cervical Plate
• 18257200018154: 54mm Two Level Cervical Plate
• 18257200018147: 52mm Three Level Cervical Plate
• 18257200018130: 52mm Two Level Cervical Plate
• 18257200018123: 110mm Five Level Cervical Plate
• 18257200018116: 50mm Three Level Cervical Plate