Cortera

GUDID 00840311206568

Screw, Poly, MIS, Cann Iliac, 10.5x100

Xtant Medical Holdings, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840311206568
• NIH Device Record Key: 24448f0c-d271-40c2-9332-5699a39438bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cortera
• Version Model Number: 150151-05100
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, 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(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840311206568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221403

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00840311206568]

Moist Heat or Steam Sterilization

[00840311206568]

Moist Heat or Steam Sterilization

[00840311206568]

Moist Heat or Steam Sterilization

[00840311206568]

Moist Heat or Steam Sterilization

[00840311206568]

Moist Heat or Steam Sterilization

[00840311206568]

Moist Heat or Steam Sterilization

[00840311206568]

Moist Heat or Steam Sterilization

[00840311206568]

Moist Heat or Steam Sterilization

[00840311206568]

Moist Heat or Steam Sterilization

[00840311206568]

Moist Heat or Steam Sterilization

[00840311206568]

Moist Heat or Steam Sterilization

[00840311206568]

Moist Heat or Steam Sterilization

[00840311206568]

Moist Heat or Steam Sterilization

[00840311206568]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-05-22
• Device Publish Date: 2023-01-06

On-Brand Devices [Cortera]

• 00840311211067: Dilator, MIS, Initial, MT
• 00840311210800: Rod Template, 150
• 00840311210787: Ball Tip Probe, Single Sided
• 00840311210589: Tap, Cann, Jacobs, 12.5
• 00840311210572: Tap, Cann, Jacobs, 11.5
• 00840311210565: Tap, Cann, Jacobs, 10.5
• 00840311210558: Tap, Cann, Jacobs, 9.5
• 00840311210541: Tap, Cann, Jacobs, 8.5
• 00840311210534: Tap, Cann, Jacobs, 8.0
• 00840311210527: Tap, Cann, Jacobs, 7.5
• 00840311210510: Tap, Cann, Jacobs, 7.0
• 00840311210503: Tap, Cann, Jacobs, 6.5
• 00840311210497: Tap, Cann, Jacobs, 6.0
• 00840311210480: Tap, Cann, Jacobs, 5.5
• 00840311210473: Tap, Cann, Jacobs, 5.0
• 00840311210466: Tap, Cann, Jacobs, 4.5
• 00840311210459: Tap, Cann, Jacobs, 4.0
• 00840311210305: Tap, Cann, 12.5
• 00840311210299: Tap, Cann, 11.5
• 00840311210282: Tap, Cann, 10.5
• 00840311210275: Tap, Cann, 9.5
• 00840311210268: Tap, Cann, 8.5
• 00840311210251: Tap, Cann, 8.0
• 00840311210244: Tap, Cann, 7.5
• 00840311210237: Tap, Cann, 7.0
• 00840311210220: Tap, Cann, 6.5
• 00840311210213: Tap, Cann, 6.0
• 00840311210206: Tap, Cann, 5.5
• 00840311210190: Tap, Cann, 5.0
• 00840311210183: Tap, Cann, 4.5
• 00840311210176: Tap, Cann, 4.0
• 00840311210015: Tap, Solid, Jacobs, 12.5
• 00840311210008: Tap, Solid, Jacobs, 11.5
• 00840311209996: Tap, Solid, Jacobs, 10.5
• 00840311209989: Tap, Solid, Jacobs, 9.5
• 00840311209972: Tap, Solid, Jacobs, 8.5
• 00840311209965: Tap, Solid, Jacobs, 8.0
• 00840311209958: Tap, Solid, Jacobs, 7.5
• 00840311209941: Tap, Solid, Jacobs, 7.0
• 00840311209934: Tap, Solid, Jacobs, 6.5
• 00840311209927: Tap, Solid, Jacobs, 6.0
• 00840311209910: Tap, Solid, Jacobs, 5.5
• 00840311209903: Tap, Solid, Jacobs, 5.0
• 00840311209897: Tap, Solid, Jacobs, 4.5
• 00840311209880: Tap, Solid, Jacobs, 4.0
• 00840311209712: Tap, Solid, 12.5
• 00840311209705: Tap, Solid, 11.5
• 00840311209699: Tap, Solid, 10.5
• 00840311209682: Tap, Solid, 9.5
• 00840311209675: Tap, Solid, 8.5