Spider Cervical Plating System

GUDID M697N600001171

62mm, Three Level Cervical Plate

Xtant Medical Holdings, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: M697N600001171
• NIH Device Record Key: f46904b5-8ae0-4726-979c-30d7ac62196b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spider Cervical Plating System
• Version Model Number: N60000117
• 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: true
• 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

• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter
• Length: 62 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697N600001171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052292

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam Sterilization

[M697N600001171]

Moist Heat or Steam 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: 2015-09-04

On-Brand Devices [Spider Cervical Plating System]

• M697X00900200: Assembly, Single Barrel All-In-One Drill Guide
• M697X00900100: Assembly, Self Retaining Double Barrel Guide
• M697X00900010: Assembly, Double Barrel Guide
• M697N600019940: Spider System Fixation Pin, Barbed, .70
• M697N600019930: Spider System Fixation Pin, Barbed, .60
• M697N600019920: Spider System Temporary Fixation Pin, .70
• M697N600015200: ASSEMBLY, SELF-CENTERING BONE AWL
• M697N600015140: 14mm SPIDER BONE AWL
• M697N600015120: 12mm SPIDER BONE AWL
• M697N600015030: NON-RATCHETING T-HANDLE MINI AO DRIVER
• M697N600015020: RATCHETING MINI AO DRIVER
• M697N600015000: STRAIGHT SCREWDRIVER ASSEMBLY
• M697N600010650: Spider 4-Level Cervical Plate Caddy
• M697N60001064LTCS0: Spider Low Torque Screw Caddy Set, Spider System
• M697N60001064LT0: Spider Low Torque Screw Caddy, Spider System
• M697N600010640: Spider Screw Caddy, Spider System
• M697N600010630: Spider Cervical Plate Caddy
• M697N600010500: Single Barrel Fixed Drill Guide Assembly
• M697N60001018LTCS0: Spider 18mm Low Torque Screw Caddy Set, Spider System
• M697N60001018LT0: Spider 18mm Low Torque Screw Caddy, Spider System
• M697N600010180: 18mm Spider Cervical Plate Screw Caddy, Spider System
• M697N600009270: AO Hex Driver
• M697N600009260: AO Hex Driver Assy
• M697N600004820: Neuro Caliper
• M697N600002010: Sterilization Case, Spider System
• M697N600001920: Plate Bender
• M697N600001900: Screw Removal Device
• M697N600001800: Single Barrel Variable Drill Guide Assembly
• M697N600001770: 16mm Drill Bit
• M697N600001760: 14mm Drill Bit
• M697N600001750: 12mm Drill Bit
• M697N600001700: 4mm Tap Assembly
• M697N600001650: Bone Awl Assembly
• M697N600001600: Screwdriver Assembly
• M697N600001590: Spider System Threaded Temporary Fixation Pin
• M697N60000152LT1: 4.25mm x 16mm Screw (Fixed), LOW TORQUE
• M697N600001521: 4.25mm x 16mm Screw (Fixed)
• M697N60000151LT1: 4.25mm x 14mm Screw (Fixed), LOW TORQUE
• M697N600001511: 4.25mm x 14mm Screw (Fixed)
• M697N60000150LT1: 4.25mm x 12mm Screw (Fixed), LOW TORQUE
• M697N600001501: 4.25mm x 12mm Screw (Fixed)
• M697N60000147LT1: 4mm x 16mm Screw (Fixed), LOW TORQUE
• M697N600001471: 4mm x 16mm Screw (Fixed)
• M697N60000146LT1: 4mm X 14mm Screw (Fixed), LOW TORQUE
• M697N600001461: 4mm X 14mm Screw (Fixed)
• M697N60000145LT1: 4mm X 12mm Screw (Fixed), LOW TORQUE
• M697N600001451: 4mm X 12mm Screw (Fixed)
• M697N60000142LT1: 4.25mm x 16mm Screw (Variable), LOW TORQUE
• M697N600001421: 4.25mm x 16mm Screw (Variable)
• M697N60000141LT1: 4.25mm x 14mm Screw (Variable), LOW TORQUE