K2M Patient Specific 811-H655BAC

GUDID 10888857413054

Contoured, Deformity, MESA Rail CoCr

K2M, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10888857413054
• NIH Device Record Key: 575cf91a-07e0-4a5b-9772-651d295340a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K2M Patient Specific
• Version Model Number: 811-H655BAC
• Catalog Number: 811-H655BAC
• Company DUNS: 146060863
• Company Name: K2M, 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: 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(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.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

• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857413054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180376

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

[10888857413054]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-09
• Device Publish Date: 2018-06-07

On-Brand Devices [K2M Patient Specific]

• 10888857413054: Contoured, Deformity, MESA Rail CoCr
• 10888857413047: Contoured, Deformity, MESA Rail Ti
• 10888857413030: Contoured Deformity Rod, Size Ø5.5 CoCr
• 10888857413023: Contoured Deformity Rod, Size Ø5.5 Ti
• 10888857548701: Contoured Deformity Rod Size Ø6.0 CoCr
• 10888857548695: Contoured Deformity Rod Size Ø6.0 Ti
• 10888857413269: Rod Template