H-Graft Interspinous Allograft

GUDID M697C07800240

Special Instrument, H-Graft Dorsal Inserter, Interspinous Cortical Block Assembly

X-SPINE SYSTEMS, INC.

Cadaveric-donor bone allograft

• Primary Device ID: M697C07800240
• NIH Device Record Key: 506d5bf7-dcf8-4980-b853-3a8b59bafed4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H-Graft Interspinous Allograft
• Version Model Number: C078-0024
• 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: 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: 1-888-886-9354
• 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	M697C07800240 [Direct Marking]
HIBCC	M697C07800241 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

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

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

Moist Heat or Steam Sterilization

[M697C07800240]

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

Devices Manufactured by X-SPINE SYSTEMS, INC.

• 00849777011563 - DBM Putty 1.0cc: 2021-05-27 1.0cc (Jar)
• 00849777011570 - DMB Putty 10.0cc: 2021-05-27 10.0cc (Jar)
• 00849777011587 - DBM Putty 1.0cc - Syringe: 2021-05-27 1.0cc (Syringe)
• 00849777011594 - DBM Putty 10.0cc - Syringe: 2021-05-27 10.0cc (Syringe)
• 00889795113238 - BEAST Injectable Putty: 2021-05-27 BEAST Injectable Putty, 1.0cc
• 00889795113245 - BEAST Injectable Putty: 2021-05-27 BEAST Injectable Putty, 2.5cc
• 00889795113252 - BEAST Injectable Putty: 2021-05-27 BEAST Injectable Putty, 5.0cc
• 00889795113269 - BEAST Injectable Putty: 2021-05-27 BEAST Injectable Putty, 10cc