Irix-A Lumbar Integrated Fusion System

GUDID M697C0804230130

423013 GUIDED INSERTER, ASSEMBLY

X-SPINE SYSTEMS, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: M697C0804230130
• NIH Device Record Key: 7952ca3d-fe27-4c55-9088-064a2aec32a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irix-A Lumbar Integrated Fusion System
• Version Model Number: C080-423013
• 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(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697C0804230130 [Direct Marking]
HIBCC	M697C0804230131 [Primary]

FDA Product Code

• HWA: IMPACTOR

Sterilization

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

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

[M697C0804230130]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-08-30

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

• M697C08001080: Irix-A Smooth shaft Universal Joint Driver
• M697C08001070: Irix-A Smooth Driver
• M697X08042301924TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 24°, 19mm (STERILE)
• M697X08042301920TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 19mm (STERILE)
• M697X08042301916TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 16°, 19mm (STERILE)
• M697X08042301724TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 24°, 17mm (STERILE)
• M697X08042301720TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 17mm (STERILE)
• M697X08042301716TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 16°, 17mm (STERILE)
• M697X08042301524TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 24°, 15mm (STERILE)
• M697X08042301520TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 15mm (STERILE)
• M697X08042301516TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 16°, 15mm (STERILE)
• M697X08042301320TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 13mm (STERILE)
• M697X08042301316TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 16°, 13mm (STERILE)
• M697X08042301116TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 16°, 11mm (STERILE)
• M697X08038281924TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 24°, 19mm (STERILE)
• M697X08038281920TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 20°, 19mm (STERILE)
• M697X08038281916TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 16°, 19mm (STERILE)
• M697X08038281724TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 24°, 17mm (STERILE)
• M697X08038281720TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 20°, 17mm (STERILE)
• M697X08038281716TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 16°, 17mm (STERILE)
• M697X08038281524TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 24°, 15mm (STERILE)
• M697X08038281520TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 20°, 15mm (STERILE)
• M697X08038281516TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 16°, 15mm (STERILE)
• M697X08038281320TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 20°, 13mm (STERILE)
• M697X08038281316TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 16°, 13mm (STERILE)
• M697X08038281116TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 16°, 11mm (STERILE)
• M697X08033261924TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 24°, 19mm (STERILE)
• M697X08033261920TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 20°, 19mm (STERILE)
• M697X08033261916TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 16°, 19mm (STERILE)
• M697X08033261724TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 24°, 17mm (STERILE)
• M697X08033261720TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 20°, 17mm (STERILE)
• M697X08033261716TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 16°, 17mm (STERILE)
• M697X08033261524TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 24°, 15mm (STERILE)
• M697X08033261520TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 20°, 15mm (STERILE)
• M697X08033261516TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 16°, 15mm (STERILE)
• M697X08033261324TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 24°, 13mm (STERILE)
• M697X08033261320TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 20°, 13mm (STERILE)
• M697X08033261316TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 16°, 13mm (STERILE)
• M697X08033261120TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 20°, 11mm (STERILE)
• M697X08033261116TSTR1: IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 16°, 11mm (STERILE)
• M697C0804230190: 423019 GUIDED INSERTER, ASSEMBLY
• M697C0804230170: 423017 GUIDED INSERTER, ASSEMBLY
• M697C0804230150: 423015 GUIDED INSERTER, ASSEMBLY
• M697C0804230130: 423013 GUIDED INSERTER, ASSEMBLY
• M697C0804230110: 423011 GUIDED INSERTER, ASSEMBLY
• M697C0803828190: 382819 GUIDED INSERTER, ASSEMBLY
• M697C0803828150: 382815 GUIDED INSERTER, ASSEMBLY
• M697C0803828130: 382813 GUIDED INSERTER, ASSEMBLY
• M697C0803828110: 382811 GUIDED INSERTER, ASSEMBLY
• M697C0803326190: 332619 GUIDED INSERTER, ASSEMBLY