EVEREST Spinal System 2911-06085

GUDID 10888857042162

Polyaxial Screw Size Ø6.0x85 mm

K2M, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10888857042162
• NIH Device Record Key: 41033ed5-8bfa-482b-92df-ffd1d57aa8b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVEREST Spinal System
• Version Model Number: 2911-06085
• Catalog Number: 2911-06085
• Company DUNS: 146060863
• Company Name: K2M, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com

Device Dimensions

• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857042162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132757

FDA Product Code

• NKG: Posterior cervical screw system

Sterilization

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

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

[10888857042162]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-05
• Device Publish Date: 2022-04-27

On-Brand Devices [EVEREST Spinal System]

• 10888857469631: Transverse Coupler, Size Ø17.3
• 10888857469624: Transverse Coupler, Size Ø16.1
• 10888857469617: Transverse Coupler, Size Ø14.4
• 10888857484900: Straight Lumbar Probe
• 10888857550742: Ball Tip Feeler
• 10888857551114: Cannulated Probe
• 10888857551084: Adjustable Hook Housing
• 10888857551077: Angled Hook (Right)
• 10888857551060: Angled Hook (Left)
• 10888857551053: Hook
• 10888857551862: Parallel Distractor
• 10888857551855: Parallel Compressor
• 10888857042186: Polyaxial Screw Size Ø6.0x95 mm
• 10888857042179: Polyaxial Screw Size Ø6.0x90 mm
• 10888857042162: Polyaxial Screw Size Ø6.0x85 mm
• 10888857042155: Polyaxial Screw Size Ø6.0x80 mm
• 10888857042148: Polyaxial Screw Size Ø6.0x75 mm
• 10888857042131: Polyaxial Screw Size Ø6.0x70 mm
• 10888857042117: Polyaxial Screw Size Ø6.0x60 mm
• 10888857042100: Polyaxial Screw Size Ø6.0x55 mm
• 10888857042094: Polyaxial Screw Size Ø6.0x50 mm
• 10888857042087: Polyaxial Screw Size Ø6.0x45 mm
• 10888857042070: Polyaxial Screw Size Ø6.0x40 mm
• 10888857042063: Polyaxial Screw Size Ø6.0x35 mm
• 10888857042056: Polyaxial Screw Size Ø6.0x30 mm
• 10888857042049: Polyaxial Screw Size Ø6.0x25 mm
• 10888857042032: Polyaxial Screw Size Ø6.0x110 mm
• 10888857042025: Polyaxial Screw Size Ø6.0x105 mm
• 10888857042018: Polyaxial Screw Size Ø6.0x100 mm
• 10888857550711: Quick Connect Adapter
• 10888857384415: French Rod Bender Ø5.5-6.0 mm
• 10888857551992: Compressor
• 10888857551985: Anti Torque Handle
• 10888857552104: Curved Thoracic Probe Size 288 mm
• 10888857552098: Curved Thoracic Probe Size 238 mm
• 10888857552081: Straight Thoracic Probe Size 288 mm
• 10888857552074: Straight Thoracic Probe Size 238 mm
• 10888857433960: MI Rod Inserter
• 10888857348035: Driver, Height Adjustment Size 25 (Long)
• 10888857348028: Driver, Height Adjustment Size 25 (Short)
• 10888857555754: T-handle
• 10888857454774: Guidewire Holder
• 10888857383395: Screw Head Adjuster
• 10888857555877: Curved Thoracic Probe
• 10888857555860: Straight Thoracic Probe
• 10888857553811: Tapered Driver, Hex Size 30
• 10888857472372: Deformity Rod Reducer
• 10888857423541: Final Shear Driver
• 10888857421813: Shear Set Screw Ejector
• 10888857421776: Anti-Torque Alignment Tube Shear Set Screw (Short)