Invictus

GUDID 00190376648101

POLYAXIAL REDUCTION SCREW, 3.5mm X 40mm

ALPHATEC SPINE, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00190376648101
• NIH Device Record Key: 27eefec6-8a32-49a7-bf1c-3c4fa117d496
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invictus
• Version Model Number: 18030-35-40
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376648101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203125

FDA Product Code

• NKG: Posterior cervical screw system

Sterilization

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

[00190376648101]

Moist Heat or Steam Sterilization

[00190376648101]

Moist Heat or Steam Sterilization

[00190376648101]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-23
• Device Publish Date: 2025-01-15

On-Brand Devices [Invictus]

• 00190376240664: Pedicle Hook, 12.5mm
• 00190376240657: Pedicle Hook, 11.5mm
• 00190376234168: Open-Closed Revision Connector, 14mm
• 00190376234151: Open-Closed Revision Connector, 13mm
• 00190376234144: Open-Closed Revision Connector, 12mm
• 00190376234137: Open-Closed Revision Connector, 11mm
• 00190376234120: Closed-Side Loading Revision Connector, 18mm
• 00190376234113: Closed-Side Loading Revision Connector, 17mm
• 00190376234106: Closed-Side Loading Revision Connector, 16mm
• 00190376234090: Closed-Side Loading Revision Connector, 15mm
• 00190376234083: Closed-Side Loading Revision Connector, 14mm
• 00190376234076: Closed-Side Loading Revision Connector, 13mm
• 00190376234069: Closed-Side Loading Revision Connector, 12mm
• 00190376234052: Closed-Side Loading Revision Connector, 11mm
• 00190376234045: Open-Closed Revision Connector, 18mm
• 00190376234038: Open-Closed Revision Connector, 17mm
• 00190376234021: Open-Closed Revision Connector, 16mm
• 00190376234014: Open-Closed Revision Connector, 15mm
• 00190376233598: Angled Hook, Left, Long, 12.5mm
• 00190376233581: Angled Hook, Left, Long, 11.5mm
• 00190376233574: Angled Hook, Left, Long, 10.5mm
• 00190376233567: Angled Hook, Left, Long, 9.5mm
• 00190376233550: Angled Hook, Left, Long, 8.5mm
• 00190376233543: Angled Hook, Left, Long, 7.5mm
• 00190376233536: Angled Hook, Left, Long, 6.5mm
• 00190376233529: Angled Hook, Left, Long, 5.5mm
• 00190376233512: Angled Hook, Left, 12.5mm
• 00190376233505: Angled Hook, Left, 11.5mm
• 00190376233499: Angled Hook, Left, 10.5mm
• 00190376233482: Angled Hook, Left, 9.5mm
• 00190376233475: Angled Hook, Left, 8.5mm
• 00190376233321: Offset Hook, Right, 12.5mm
• 00190376233314: Offset Hook, Right, 11.5mm
• 00190376233307: Offset Hook, Right, 10.5mm
• 00190376233291: Offset Hook, Right, 9.5mm
• 00190376233284: Offset Hook, Right, 8.5mm
• 00190376233277: Offset Hook, Right, 7.5mm
• 00190376233260: Offset Hook, Right, 6.5mm
• 00190376233253: Offset Hook, Right, 5.5mm
• 00190376233246: Angled Hook, Left, 7.5mm
• 00190376233239: Angled Hook, Left, 6.5mm
• 00190376233222: Angled Hook, Left, 5.5mm
• 00190376233055: Angled Hook, Right, Long, 12.5mm
• 00190376233048: Angled Hook, Right, Long, 11.5mm
• 00190376233031: Angled Hook, Right, Long, 10.5mm
• 00190376233024: Angled Hook, Right, Long, 9.5mm
• 00190376233017: Angled Hook, Right, Long, 8.5mm
• 00190376233000: Angled Hook, Right, Long, 7.5mm
• 00190376232997: Angled Hook, Right, Long, 6.5mm
• 00190376232980: Angled Hook, Right, Long, 5.5mm