Xspan Laminoplasty Fixation System

GUDID M697X0853006STR1

SCREW, 3.0mm x 6mm LONG, SELF-DRILLING

Xtant Medical Holdings, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: M697X0853006STR1
• NIH Device Record Key: 778eb073-674b-46ed-b6ac-ca2c09bd3555
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xspan Laminoplasty Fixation System
• Version Model Number: X085-3006-STR
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com

Device Dimensions

• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X0853006STR1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160114

FDA Product Code

• NQW: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

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

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

[M697X0853006STR1]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-06-03
• Device Publish Date: 2016-04-08

On-Brand Devices [Xspan Laminoplasty Fixation System]

• M697X0853009STR1: SCREW, 3.0mm x 9mm LONG, SELF-DRILLING
• M697X08530091: SCREW, 3.0mm x 9mm LONG, SELF-DRILLING
• M697X0853008STR1: SCREW, 3.0mm x 8mm LONG, SELF-DRILLING
• M697X08530081: SCREW, 3.0mm x 8mm LONG, SELF-DRILLING
• M697X0853007STR1: SCREW, 3.0mm x 7mm LONG, SELF-DRILLING
• M697X08530071: SCREW, 3.0mm x 7mm LONG, SELF-DRILLING
• M697X0853006STR1: SCREW, 3.0mm x 6mm LONG, SELF-DRILLING
• M697X08530061: SCREW, 3.0mm x 6mm LONG, SELF-DRILLING
• M697X0853005STR1: SCREW, 3.0mm x 5mm LONG, SELF-DRILLING
• M697X08530051: SCREW, 3.0mm x 5mm LONG, SELF-DRILLING
• M697X0852609STR1: SCREW, 2.6mm x 9mm LONG, SELF-DRILLING
• M697X08526091: SCREW, 2.6mm x 9mm LONG, SELF-DRILLING
• M697X0852608STR1: SCREW, 2.6mm x 8mm LONG, SELF-DRILLING
• M697X08526081: SCREW, 2.6mm x 8mm LONG, SELF-DRILLING
• M697X0852607STR1: SCREW, 2.6mm x 7mm LONG, SELF-DRILLING
• M697X08526071: SCREW, 2.6mm x 7mm LONG, SELF-DRILLING
• M697X0852606STR1: SCREW, 2.6mm x 6mm LONG, SELF-DRILLING
• M697X08526061: SCREW, 2.6mm x 6mm LONG, SELF-DRILLING
• M697X0852605STR1: SCREW, 2.6mm x 5mm LONG, SELF-DRILLING
• M697X08526051: SCREW, 2.6mm x 5mm LONG, SELF-DRILLING
• M697X0850312H06RUSTR1: 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED
• M697X0850312H06RU1: 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED
• M697X0850312H06RSTR1: 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT
• M697X0850312H06R1: 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT
• M697X0850312H06LUSTR1: 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
• M697X0850312H06LU1: 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
• M697X0850312H06LSTR1: 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT
• M697X0850312H06L1: 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT
• M697X0850312H04RUSTR1: 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT, UNSLOTTED
• M697X0850312H04RU1: 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT, UNSLOTTED
• M697X0850312H04RSTR1: 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT
• M697X0850312H04R1: 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT
• M697X0850312H04LUSTR1: 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
• M697X0850312H04LU1: 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
• M697X0850312H04LSTR1: 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT
• M697X0850312H04L1: 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT
• M697X0850312F06RSTR1: 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 6mm THROAT
• M697X0850312F06R1: 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 6mm THROAT
• M697X0850312F06LSTR1: 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 6mm THROAT
• M697X0850312F06L1: 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 6mm THROAT
• M697X0850312F04RSTR1: 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 4mm THROAT
• M697X0850312F04R1: 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 4mm THROAT
• M697X0850312F04LSTR1: 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 4mm THROAT
• M697X0850312F04L1: 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 4mm THROAT
• M697X0850310H06RUSTR1: 10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED
• M697X0850310H06RU1: 10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED
• M697X0850310H06RSTR1: 10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT
• M697X0850310H06R1: 10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT
• M697X0850310H06LUSTR1: 10mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
• M697X0850310H06LU1: 10mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED