Primus

GUDID 00840466900359

8.5mm x 80mm Primus Cannulated

SPINAL ELEMENTS, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840466900359
• NIH Device Record Key: deb32a3e-0200-4dd9-87f7-e2c62a9564d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primus
• Version Model Number: 66012-085-080
• Company DUNS: 610712213
• Company Name: SPINAL ELEMENTS, 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: true
• 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: 7606070121
• Email: customerservice@spinalelements.com
• Phone: 7606070121
• Email: customerservice@spinalelements.com
• Phone: 7606070121
• Email: customerservice@spinalelements.com
• Phone: 7606070121
• Email: customerservice@spinalelements.com
• Phone: 7606070121
• Email: customerservice@spinalelements.com
• Phone: 7606070121
• Email: customerservice@spinalelements.com
• Phone: 7606070121
• Email: customerservice@spinalelements.com
• Phone: 7606070121
• Email: customerservice@spinalelements.com
• Phone: 7606070121
• Email: customerservice@spinalelements.com
• Phone: 7606070121
• Email: customerservice@spinalelements.com
• Phone: 7606070121
• Email: customerservice@spinalelements.com
• Phone: 7606070121
• Email: customerservice@spinalelements.com
• Phone: 7606070121
• Email: customerservice@spinalelements.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840466900359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243916

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00840466900359]

Moist Heat or Steam Sterilization

[00840466900359]

Moist Heat or Steam Sterilization

[00840466900359]

Moist Heat or Steam Sterilization

[00840466900359]

Moist Heat or Steam Sterilization

[00840466900359]

Moist Heat or Steam Sterilization

[00840466900359]

Moist Heat or Steam Sterilization

[00840466900359]

Moist Heat or Steam Sterilization

[00840466900359]

Moist Heat or Steam Sterilization

[00840466900359]

Moist Heat or Steam Sterilization

[00840466900359]

Moist Heat or Steam Sterilization

[00840466900359]

Moist Heat or Steam Sterilization

[00840466900359]

Moist Heat or Steam Sterilization

[00840466900359]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-21
• Device Publish Date: 2026-01-13

On-Brand Devices [Primus]

• 00840606187107: Ø5.5mm x 30mm, Ti MIS Lordotic Rod
• 00840466900359: 8.5mm x 80mm Primus Cannulated
• 00840466900342: 8.5mm x 70mm Primus Cannulated
• 00840466900311: 8.5mm x 50mm Primus Cannulated
• 00840466900083: 5.5mm x 50mm Primus Cannulated
• 00840606187084: Ø5.5mm x 200mm, Ti MIS Lordotic Rod
• 00840606187077: Ø5.5mm x 190mm, Ti MIS Lordotic Rod
• 00840606187060: Ø5.5mm x 180mm, Ti MIS Lordotic Rod
• 00840606187053: Ø5.5mm x 170mm, Ti MIS Lordotic Rod
• 00840606187046: Ø5.5mm x 160mm, Ti MIS Lordotic Rod
• 00840606187039: Ø5.5mm x 150mm, Ti MIS Lordotic Rod
• 00840606187022: Ø5.5mm x 140mm, Ti MIS Lordotic Rod
• 00840606187015: Ø5.5mm x 130mm, Ti MIS Lordotic Rod
• 00840606187008: Ø5.5mm x 125mm, Ti MIS Lordotic Rod
• 00840606186995: Ø5.5mm x 120mm, Ti MIS Lordotic Rod
• 00840606186988: Ø5.5mm x 115mm, Ti MIS Lordotic Rod
• 00840606186971: Ø5.5mm x 110mm, Ti MIS Lordotic Rod
• 00840606186964: Ø5.5mm x 105mm, Ti MIS Lordotic Rod
• 00840606186957: Ø5.5mm x 100mm, Ti MIS Lordotic Rod
• 00840606186940: Ø5.5mm x 95mm, Ti MIS Lordotic Rod
• 00840606186933: Ø5.5mm x 90mm, Ti MIS Lordotic Rod
• 00840606186926: Ø5.5mm x 85mm, Ti MIS Lordotic Rod
• 00840606186919: Ø5.5mm x 80mm, Ti MIS Lordotic Rod
• 00840606186902: Ø5.5mm x 75mm, Ti MIS Lordotic Rod
• 00840606186896: Ø5.5mm x 70mm, Ti MIS Lordotic Rod
• 00840606186889: Ø5.5mm x 65mm, Ti MIS Lordotic Rod
• 00840606186872: Ø5.5mm x 60mm, Ti MIS Lordotic Rod
• 00840606186865: Ø5.5mm x 55mm, Ti MIS Lordotic Rod
• 00840606186858: Ø5.5mm x 50mm, Ti MIS Lordotic Rod
• 00840606186841: Ø5.5mm x 45mm, Ti MIS Lordotic Rod
• 00840606186834: Ø5.5mm x 40mm, Ti MIS Lordotic Rod
• 00840606186827: Ø5.5mm x 35mm, Ti MIS Lordotic Rod
• 00840606185738: Primus 10.5mm Navigated Solid Tap
• 00840606185721: Primus 9.5mm Navigated Solid Tap
• 00840606185714: Primus 9.0mm Navigated Solid Tap
• 00840606185707: Primus 8.5mm Navigated Solid Tap
• 00840606185691: Primus 8.0mm Navigated Solid Tap
• 00840606185684: Primus 7.5mm Navigated Solid Tap
• 00840606185677: Primus 7.0mm Navigated Solid Tap
• 00840606185660: Primus 6.5mm Navigated Solid Tap
• 00840606185653: Primus 6.0mm Navigated Solid Tap
• 00840606185646: Primus 5.5mm Navigated Solid Tap
• 00840606185639: Primus 5.0mm Navigated Solid Tap
• 00840606185622: Primus 4.5mm Navigated Solid Tap
• 00840606185615: Primus 4.0mm Navigated Solid Tap
• 00840606185608: Primus 10.5mm Navigated Cannulated Tap
• 00840606185592: Primus 9.5mm Navigated Cannulated Tap
• 00840606185585: Primus 9.0mm Navigated Cannulated Tap
• 00840606185578: Primus 8.5mm Navigated Cannulated Tap
• 00840606185561: Primus 8.0mm Navigated Cannulated Tap