Complete Cervical 27-14-3511

GUDID 10889981040994

Screw - Self-Drilling - 3.5x11mm

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981040994
• NIH Device Record Key: 41c6d736-b798-4714-9b6b-e5b85388b914
• Commercial Distribution Discontinuation: 2016-09-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Complete Cervical
• Version Model Number: 27-14-3511
• Catalog Number: 27-14-3511
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• 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: false
• 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(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981040994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102323

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[10889981040994]

Moist Heat or Steam Sterilization

[10889981040994]

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: 2015-09-24

On-Brand Devices [Complete Cervical]

• 10889981041113: Screw Self-Drilling - 4.0x19mm
• 10889981041106: Screw Self-Drilling - 4.0x17mm
• 10889981041090: Screw Self-Drilling - 4.0x15mm
• 10889981041083: Screw Self-Drilling - 4.0x13mm
• 10889981041076: Screw Self-Drilling - 4.0x11mm
• 10889981041069: Screw - Self-Drilling - 3.5x18mm
• 10889981041052: Screw - Self-Drilling - 3.5x17mm
• 10889981041045: Screw - Self-Drilling - 3.5x16mm
• 10889981041038: Screw - Self-Drilling - 3.5x15mm
• 10889981041021: Screw - Self-Drilling - 3.5x14mm
• 10889981041014: Screw - Self-Drilling - 3.5x13mm
• 10889981041007: Screw - Self-Drilling - 3.5x12mm
• 10889981040994: Screw - Self-Drilling - 3.5x11mm
• 10889981040987: Screw - Self-Drilling - 3.5x10mm
• 10889981040970: Screw Self-Tapping - 4.0x19mm
• 10889981040963: Screw Self-Tapping - 4.0x17mm
• 10889981040956: Screw Self-Tapping - 4.0x15mm
• 10889981040949: Screw Self-Tapping - 4.0x13mm
• 10889981040932: Screw Self-Tapping - 4.0x11mm
• 10889981040925: Screw - Self-Tapping - 3.5x18mm
• 10889981040918: Screw - Self-Tapping - 3.5x17mm
• 10889981040901: Screw - Self-Tapping - 3.5x16mm
• 10889981040895: Screw - Self-Tapping - 3.5x15mm
• 10889981040888: Screw - Self-Tapping - 3.5x14mm
• 10889981040871: Screw - Self Tapping - 3.5x13mm
• 10889981040864: Screw - Self-Tapping - 3.5x12mm
• 10889981040857: Screw - Self-Tapping - 3.5x11mm
• 10889981040840: Screw - Self-Tapping - 3.5x10mm
• 10889981040833: Screw Self-Drilling - 4.0x19mm
• 10889981040826: Screw Self-Drilling - 4.0x17mm
• 10889981040819: Screw Self-Drilling - 4.0x15mm
• 10889981040802: Screw Self-Drilling - 4.0x13mm
• 10889981040796: Screw Self-Drilling - 4.0x11mm
• 10889981040789: Screw - Self-Drilling - 3.5x18mm
• 10889981040772: Screw - Self-Drilling - 3.5x17mm
• 10889981040765: Screw - Self-Drilling - 3.5x16mm
• 10889981040758: Screw - Self-Drilling - 3.5x15mm
• 10889981040741: Screw - Self-Drilling - 3.5x14mm
• 10889981040734: Screw - Self-Drilling - 3.5x13mm
• 10889981040727: Screw - Self-Drilling - 3.5x12mm
• 10889981040710: Screw - Self-Drilling - 3.5x11mm
• 10889981040703: Screw - Self-Drilling - 3.5x10mm
• 10889981040697: Screw Self-Tapping - 4.0x19mm
• 10889981040680: Screw Self-Tapping - 4.0x17mm
• 10889981040673: Screw Self-Tapping - 4.0x15mm
• 10889981040666: Screw Self-Tapping - 4.0x13mm
• 10889981040659: Screw Self-Tapping - 4.0x11mm
• 10889981040642: Screw - Self-Tapping - 3.5x18mm
• 10889981040635: Screw - Self-Tapping - 3.5x17mm
• 10889981040628: Screw - Self-Tapping - 3.5x16mm