YUKON OCT Spinal System 7601-04528

GUDID 10888857349803

Polyaxial Screw, Size Ø4.5x28 mm

K2M, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10888857349803
• NIH Device Record Key: 36164467-80e5-4919-a138-d779f3bbc187
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YUKON OCT Spinal System
• Version Model Number: 7601-04528
• Catalog Number: 7601-04528
• 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

Device Dimensions

• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857349803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171444

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

[10888857349803]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-25

On-Brand Devices [YUKON OCT Spinal System]

• 10888857398344: Axial Rod Connector, Size Ø3.5 mm/Ø5.5/6.0 mm
• 10888857398337: Parallel Rod Connector, Size Ø3.5-Ø5.5/6.0 mm, 4 Screw
• 10888857398320: Lateral Offset Connector, Size 30 mm Angled
• 10888857398313: Lateral Offset Connector, Size 25 mm Angled
• 10888857398306: Lateral Offset Connector, Size 20 mm Angled
• 10888857398290: Lateral Offset Connector, Size 15 mm Angled
• 10888857398283: Lateral Offset Connector, Size 10 mm Angled
• 10888857398276: Contoured Rod, Size Ø4.0x120 mm CoCr
• 10888857398269: Contoured Rod, Size Ø4.0x115 mm CoCr
• 10888857398252: Contoured Rod, Size Ø4.0x110 mm CoCr
• 10888857398245: Contoured Rod, Size Ø4.0x105 mm CoCr
• 10888857398238: Contoured Rod, Size Ø4.0x100 mm CoCr
• 10888857398221: Contoured Rod, Size Ø4.0x95 mm CoCr
• 10888857398214: Contoured Rod, Size Ø4.0x90 mm CoCr
• 10888857398207: Contoured Rod, Size Ø4.0x85 mm CoCr
• 10888857398191: Contoured Rod, Size Ø4.0x80 mm CoCr
• 10888857398184: Contoured Rod, Size Ø4.0x75 mm CoCr
• 10888857398177: Contoured Rod, Size Ø4.0x70 mm CoCr
• 10888857398160: Contoured Rod, Size Ø4.0x65 mm CoCr
• 10888857398153: Contoured Rod, Size Ø4.0x60 mm CoCr
• 10888857398146: Contoured Rod, Size Ø4.0x55 mm CoCr
• 10888857398139: Contoured Rod, Size Ø4.0x50 mm CoCr
• 10888857398122: Contoured Rod, Size Ø4.0x45 mm CoCr
• 10888857398115: Contoured Rod, Size Ø4.0x40 mm CoCr
• 10888857398108: Contoured Rod, Size Ø4.0x35 mm CoCr
• 10888857398092: Contoured Rod, Size Ø4.0x30 mm CoCr
• 10888857398085: Contoured Rod, Size Ø4.0x25 mm CoCr
• 10888857398078: Contoured Rod, Size Ø3.5x120 mm CoCr
• 10888857398061: Contoured Rod, Size Ø3.5x115 mm CoCr
• 10888857398054: Contoured Rod, Size Ø3.5x110 mm CoCr
• 10888857398047: Contoured Rod, Size Ø3.5x105 mm CoCr
• 10888857398030: Contoured Rod, Size Ø3.5x100 mm CoCr
• 10888857398023: Contoured Rod, Size Ø3.5x95 mm CoCr
• 10888857398016: Contoured Rod, Size Ø3.5x90 mm CoCr
• 10888857398009: Contoured Rod, Size Ø3.5x85 mm CoCr
• 10888857397996: Contoured Rod, Size Ø3.5x80 mm CoCr
• 10888857397989: Contoured Rod, Size Ø3.5x75 mm CoCr
• 10888857397972: Contoured Rod, Size Ø3.5x70 mm CoCr
• 10888857397965: Contoured Rod, Size Ø3.5x65 mm CoCr
• 10888857397958: Contoured Rod, Size Ø3.5x60 mm CoCr
• 10888857397941: Contoured Rod, Size Ø3.5x55 mm CoCr
• 10888857397934: Contoured Rod, Size Ø3.5x50 mm CoCr
• 10888857397927: Contoured Rod, Size Ø3.5x45 mm CoCr
• 10888857397910: Contoured Rod, Size Ø3.5x40 mm CoCr
• 10888857397903: Contoured Rod, Size Ø3.5x35 mm CoCr
• 10888857397897: Contoured Rod, Size Ø3.5x30 mm CoCr
• 10888857397880: Contoured Rod, Size Ø3.5x25 mm CoCr
• 10888857397873: Contoured Rod, Size Ø4.0x120 mm
• 10888857397866: Contoured Rod, Size Ø4.0x115 mm
• 10888857397859: Contoured Rod, Size Ø4.0x110 mm