EVEREST® Spinal System 5111-E55135-G1

GUDID 10888857418318

Contoured Rod, Bulleted Hex, Size Ø5.5x135 mm, CoCr

K2M, INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 10888857418318
• NIH Device Record Key: a427723c-deec-4fb3-a363-e908c45b4ef6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVEREST® Spinal System
• Version Model Number: 5111-E55135-G1
• Catalog Number: 5111-E55135-G1
• 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: true
• 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: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@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

Device Dimensions

• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 135 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857418318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132361

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-25
• Device Publish Date: 2019-01-25

On-Brand Devices [EVEREST® Spinal System]

• 10888857419858: Straight Rod, Bulleted Hex, Size Ø6.0x500 mm, CoCr
• 10888857419841: Straight Rod, Bulleted Hex, Size Ø5.5x500 mm, CoCr
• 10888857419834: Straight Rod, Bulleted Hex, Size Ø6.0x500 mm, Ti
• 10888857419407: Straight Rod, Bulleted Hex, Size Ø6.0x300 mm, CoCr
• 10888857419391: Straight Rod, Bulleted Hex, Size Ø6.0x290 mm, CoCr
• 10888857419384: Straight Rod, Bulleted Hex, Size Ø6.0x280 mm, CoCr
• 10888857419377: Straight Rod, Bulleted Hex, Size Ø6.0x275 mm, CoCr
• 10888857419360: Straight Rod, Bulleted Hex, Size Ø6.0x270 mm, CoCr
• 10888857419353: Straight Rod, Bulleted Hex, Size Ø6.0x260 mm, CoCr
• 10888857419346: Straight Rod, Bulleted Hex, Size Ø6.0x250 mm, CoCr
• 10888857419339: Straight Rod, Bulleted Hex, Size Ø6.0x240 mm, CoCr
• 10888857419322: Straight Rod, Bulleted Hex, Size Ø6.0x230 mm, CoCr
• 10888857419315: Straight Rod, Bulleted Hex, Size Ø6.0x225 mm, CoCr
• 10888857419308: Straight Rod, Bulleted Hex, Size Ø6.0x220 mm, CoCr
• 10888857419292: Straight Rod, Bulleted Hex, Size Ø6.0x210 mm, CoCr
• 10888857419285: Straight Rod, Bulleted Hex, Size Ø6.0x200 mm, CoCr
• 10888857419278: Straight Rod, Bulleted Hex, Size Ø6.0x190 mm, CoCr
• 10888857419261: Straight Rod, Bulleted Hex, Size Ø6.0x180 mm, CoCr
• 10888857419254: Straight Rod, Bulleted Hex, Size Ø6.0x175 mm, CoCr
• 10888857419247: Straight Rod, Bulleted Hex, Size Ø6.0x170 mm, CoCr
• 10888857419230: Straight Rod, Bulleted Hex, Size Ø6.0x160 mm, CoCr
• 10888857419223: Straight Rod, Bulleted Hex, Size Ø5.5x300 mm, CoCr
• 10888857419216: Straight Rod, Bulleted Hex, Size Ø5.5x290 mm, CoCr
• 10888857419209: Straight Rod, Bulleted Hex, Size Ø5.5x280 mm, CoCr
• 10888857419193: Straight Rod, Bulleted Hex, Size Ø5.5x275 mm, CoCr
• 10888857419186: Straight Rod, Bulleted Hex, Size Ø5.5x270 mm, CoCr
• 10888857419179: Straight Rod, Bulleted Hex, Size Ø5.5x260 mm, CoCr
• 10888857419162: Straight Rod, Bulleted Hex, Size Ø5.5x250 mm, CoCr
• 10888857419155: Straight Rod, Bulleted Hex, Size Ø5.5x240 mm, CoCr
• 10888857419148: Straight Rod, Bulleted Hex, Size Ø5.5x230 mm, CoCr
• 10888857419131: Straight Rod, Bulleted Hex, Size Ø5.5x225 mm, CoCr
• 10888857419124: Straight Rod, Bulleted Hex, Size Ø5.5x220 mm, CoCr
• 10888857419117: Straight Rod, Bulleted Hex, Size Ø5.5x210 mm, CoCr
• 10888857419100: Straight Rod, Bulleted Hex, Size Ø5.5x200 mm, CoCr
• 10888857419094: Straight Rod, Bulleted Hex, Size Ø5.5x190 mm, CoCr
• 10888857419087: Straight Rod, Bulleted Hex, Size Ø5.5x180 mm, CoCr
• 10888857419070: Straight Rod, Bulleted Hex, Size Ø5.5x175 mm, CoCr
• 10888857419063: Straight Rod, Bulleted Hex, Size Ø5.5x170 mm, CoCr
• 10888857419056: Straight Rod, Bulleted Hex, Size Ø5.5x160 mm, CoCr
• 10888857419049: Straight Rod, Bulleted Hex, Size Ø6.0x300 mm, Ti
• 10888857419032: Straight Rod, Bulleted Hex, Size Ø6.0x290 mm, Ti
• 10888857419025: Straight Rod, Bulleted Hex, Size Ø6.0x280 mm, Ti
• 10888857419018: Straight Rod, Bulleted Hex, Size Ø6.0x275 mm, Ti
• 10888857419001: Straight Rod, Bulleted Hex, Size Ø6.0x270 mm, Ti
• 10888857418998: Straight Rod, Bulleted Hex, Size Ø6.0x260 mm, Ti
• 10888857418981: Straight Rod, Bulleted Hex, Size Ø6.0x250 mm, Ti
• 10888857418974: Straight Rod, Bulleted Hex, Size Ø6.0x240 mm, Ti
• 10888857418967: Straight Rod, Bulleted Hex, Size Ø6.0x230 mm, Ti
• 10888857418950: Straight Rod, Bulleted Hex, Size Ø6.0x225 mm, Ti
• 10888857418943: Straight Rod, Bulleted Hex, Size Ø6.0x220 mm, Ti