Silex Sacroiliac Joint Fusion System

GUDID M697C07902610

Special Instrument 8mm x 25cm Tamp Assembly

X-SPINE SYSTEMS, INC.

Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit

• Primary Device ID: M697C07902610
• NIH Device Record Key: b19f5bf7-f31f-456e-b656-a1620e6886a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silex Sacroiliac Joint Fusion System
• Version Model Number: C079-0261
• Company DUNS: 610042587
• Company Name: X-SPINE SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697C07902610 [Direct Marking]
HIBCC	M697C07902611 [Primary]

FDA Product Code

• HXG: Tamp

Sterilization

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

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-27
• Device Publish Date: 2021-05-19

On-Brand Devices [Silex Sacroiliac Joint Fusion System]

• M697C07902620: Special Instrument 8mm x 25cm Bone Funnel Assembly
• M697C07902610: Special Instrument 8mm x 25cm Tamp Assembly