Irix-A Lumbar Integrated Fusion System

GUDID M697C08001190

Special Instrument Universal Joint Tap

Xtant Medical Holdings, Inc.

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• Primary Device ID: M697C08001190
• NIH Device Record Key: b893b918-1a4e-4fe2-bd86-6954274eb572
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irix-A Lumbar Integrated Fusion System
• Version Model Number: C080-0119
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697C08001190 [Direct Marking]
HIBCC	M697C08001191 [Primary]

FDA Product Code

• HWX: Tap, Bone

Sterilization

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

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

[M697C08001190]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-01
• Device Publish Date: 2021-09-23

On-Brand Devices [Irix-A Lumbar Integrated Fusion System]

• M697X08042301924STR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 24°, 19mm (STERILE)
• M697X08042301924PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 24°, 19mm, PC (STERILE)
• M697X08042301920STR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 20°, 19mm (STERILE)
• M697X08042301920PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 20°, 19mm, PC (STERILE)
• M697X08042301916STR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 16°, 19mm (STERILE)
• M697X08042301916PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 16°, 19mm, PC (STERILE)
• M697X08042301720STR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 20°, 17mm (STERILE)
• M697X08042301720PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 20°, 17mm, PC (STERILE)
• M697X08042301716STR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 16°, 17mm (STERILE)
• M697X08042301716PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 16°, 17mm, PC (STERILE)
• M697X08042301516STR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 16°, 15mm (STERILE)
• M697X08042301516PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 16°, 15mm, PC (STERILE)
• M697X08038281924STR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 24°, 19mm (STERILE)
• M697X08038281924PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 24°, 19mm, PC (STERILE)
• M697X08038281920STR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 20°, 19mm (STERILE)
• M697X08038281920PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 20°, 19mm, PC (STERILE)
• M697X08038281916STR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 16°, 19mm (STERILE)
• M697X08038281916PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 16°, 19mm, PC (STERILE)
• M697X08038281724STR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 24°, 17mm (STERILE)
• M697X08038281724PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 24°, 17mm, PC (STERILE)
• M697X08038281720STR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 20°, 17mm (STERILE)
• M697X08038281720PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 20°, 17mm, PC (STERILE)
• M697X08038281716STR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 16°, 17mm (STERILE)
• M697X08038281716PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 16°, 17mm, PC (STERILE)
• M697X08038281520STR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 20°, 15mm (STERILE)
• M697X08038281520PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 20°, 15mm, PC (STERILE)
• M697X08038281516PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 16°, 15mm, PC (STERILE)
• M697X08038281316STR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 16°, 13mm (STERILE)
• M697X08038281316PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 16°, 13mm, PC (STERILE)
• M697X08033261924STR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 24°, 19mm (STERILE)
• M697X08033261924PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 24°, 19mm, PC (STERILE)
• M697X08033261920STR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 20°, 19mm (STERILE)
• M697X08033261920PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 20°, 19mm, PC (STERILE)
• M697X08033261916STR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 16°, 19mm (STERILE)
• M697X08033261916PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 16°, 19mm, PC (STERILE)
• M697X08033261724STR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 24°, 17mm (STERILE)
• M697X08033261724PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 24°, 17mm, PC (STERILE)
• M697X08033261720STR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 20°, 17mm (STERILE)
• M697X08033261720PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 20°, 17mm, PC (STERILE)
• M697X08033261716STR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 16°, 17mm (STERILE)
• M697X08033261716PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 16°, 17mm, PC (STERILE)
• M697X08033261520STR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 20°, 15mm (STERILE)
• M697X08033261520PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 20°, 15mm, PC (STERILE)
• M697X08033261516STR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 16°, 15mm (STERILE)
• M697X08033261516PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 16°, 15mm, PC (STERILE)
• M697X08033261316STR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 16°, 13mm (STERILE)
• M697X08033261316PCSTR1: IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 16°, 13mm, PC (STERILE)
• M697X080038281516STR1: IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 16°, 15mm (STERILE)
• M697T08042301924TR0: 42 X 30 X 19mm, 24 DEG TRIAL
• M697T08042301920TR0: 42 X 30 X 19mm, 20 DEG TRIAL