Silex Sacroiliac Joint Fusion System

GUDID M697C07902630

Special Guide Handle Assembly, Soft Tissue Shield

Xtant Medical Holdings, Inc.

Sacroiliac joint transarticular fixation/arthrodesis implantation kit

• Primary Device ID: M697C07902630
• NIH Device Record Key: 00186787-54eb-4ef7-a1b1-85a7fe1f1393
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silex Sacroiliac Joint Fusion System
• Version Model Number: C079-0263
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697C07902630 [Direct Marking]
HIBCC	M697C07902631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140079

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

[M697C07902630]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-03
• Device Publish Date: 2022-05-26

On-Brand Devices [Silex Sacroiliac Joint Fusion System]

• M697X0791270PCDT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 70mm
• M697X0791270PC1: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 70mm
• M697X0791270DT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 70mm
• M697X07912701: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 70mm
• M697X0791265PCDT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 65mm
• M697X0791265PC1: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 65mm
• M697X0791265DT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 65mm
• M697X07912651: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 65mm
• M697X0791260PCDT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 60mm
• M697X0791260PC1: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 60mm
• M697X0791260DT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 60mm
• M697X07912601: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 60mm
• M697X0791255PCDT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 55mm
• M697X0791255PC1: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 55mm
• M697X0791255DT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 55mm
• M697X07912551: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 55mm
• M697X0791250PCDT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 50mm
• M697X0791250PC1: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 50mm
• M697X0791250DT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 50mm
• M697X07912501: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 50mm
• M697X0791245PCDT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 45mm
• M697X0791245PC1: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 45mm
• M697X0791245DT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 45mm
• M697X07912451: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 45mm
• M697X0791240PCDT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 40mm
• M697X0791240PC1: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 40mm
• M697X0791240DT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 40mm
• M697X07912401: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 40mm
• M697X0791235PCDT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 35mm
• M697X0791235PC1: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 35mm
• M697X0791235DT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 35mm
• M697X07912351: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 35mm
• M697X0791230PCDT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, PLASMA COATED, 12.5mm DIA X 30mm
• M697X0791230PC1: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, PLASMA COATED, 12.5mm DIA X 30mm
• M697X0791230DT1: SILEX SACROILIAC ANCHOR IMPLANT, DUAL THREAD, 12.5mm DIA X 30mm
• M697X07912301: SILEX SACROILIAC ANCHOR IMPLANT, SINGLE THREAD, 12.5mm DIA X 30mm
• M697X07908021: WASHER, SILEX, 15mm
• M697X07908011: WASHER, SILEX, 13mm
• M697X07908001: WASHER, SILEX, 11mm
• M697X0790770DT1: SILEX SACROILIAC LOCKING IMPLANT, DUAL THREAD, 7mm DIA X 70mm
• M697X07907701: SILEX SACROILIAC LOCKING IMPLANT, SINGLE THREAD, 7mm DIA X 70mm
• M697X0790765DT1: SILEX SACROILIAC LOCKING IMPLANT, DUAL THREAD, 7mm DIA X 65mm
• M697X07907651: SILEX SACROILIAC LOCKING IMPLANT, SINGLE THREAD, 7mm DIA X 65mm
• M697X0790760DT1: SILEX SACROILIAC LOCKING IMPLANT, DUAL THREAD, 7mm DIA X 60mm
• M697X07907601: SILEX SACROILIAC LOCKING IMPLANT, SINGLE THREAD, 7mm DIA X 60mm
• M697X0790755DT1: SILEX SACROILIAC LOCKING IMPLANT, DUAL THREAD, 7mm DIA X 55mm
• M697X07907551: SILEX SACROILIAC LOCKING IMPLANT, SINGLE THREAD, 7mm DIA X 55mm
• M697X0790750DT1: SILEX SACROILIAC LOCKING IMPLANT, DUAL THREAD, 7mm DIA X 50mm
• M697X07907501: SILEX SACROILIAC LOCKING IMPLANT, SINGLE THREAD, 7mm DIA X 50mm
• M697X0790745DT1: SILEX SACROILIAC LOCKING IMPLANT, DUAL THREAD, 7mm DIA X 45mm