Axle Interspinous Fusion System

GUDID M697C06000780

18mm SPECIALTY AXLE TRIAL/RASP ASSEMBLY

Xtant Medical Holdings, Inc.

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Primary Device ID	M697C06000780
NIH Device Record Key	7716a637-4b10-4c3c-94f3-51b1d8b2c6f3
Commercial Distribution Status	In Commercial Distribution
Brand Name	Axle Interspinous Fusion System
Version Model Number	C060-0078
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(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 Dimensions

Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697C06000780 [Direct Marking]
HIBCC	M697C06000781 [Primary]

FDA Product Code

RASP

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

[M697C06000780]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2021-06-03
Device Publish Date	2016-02-23

On-Brand Devices [Axle Interspinous Fusion System]

M697X0806040X1	6.0 X 40mm, IRIX-A, RESCUE SCREW, CE MARKED
M697X08060401	6.0 X 40mm, IRIX-A, RESCUE SCREW
M697X0806035X1	6.0 X 35mm, IRIX-A, RESCUE SCREW, CE MARKED
M697X08060351	6.0 X 35mm, IRIX-A, RESCUE SCREW
M697X0806030X1	6.0 X 30mm, IRIX-A, RESCUE SCREW, CE MARKED
M697X08060301	6.0 X 30mm, IRIX-A, RESCUE SCREW
M697X0806025X1	6.0 X 25mm, IRIX-A, RESCUE SCREW, CE MARKED
M697X08060251	6.0 X 25mm, IRIX-A, RESCUE SCREW
M697X0805540STX1	5.5 X 40mm, IRIX-A, SELF TAPPING SCREW, CE MARKED
M697X0805540ST1	5.5 X 40mm, IRIX-A, SELF TAPPING SCREW
M697X0805540SDX1	5.5 X 40mm, IRIX-A, SELF DRILLING SCREW, CE MARKED
M697X0805540SD1	5.5 X 40mm, IRIX-A, SELF DRILLING SCREW
M697X0805535STX1	5.5 X 35mm, IRIX-A, SELF TAPPING SCREW, CE MARKED
M697X0805535ST1	5.5 X 35mm, IRIX-A, SELF TAPPING SCREW
M697X0805535SDX1	5.5 X 35mm, IRIX-A, SELF DRILLING SCREW, CE MARKED
M697X0805535SD1	5.5 X 35mm, IRIX-A, SELF DRILLING SCREW
M697X0805530STX1	5.5 X 30mm, IRIX-A, SELF TAPPING SCREW, CE MARKED
M697X0805530ST1	5.5 X 30mm, IRIX-A, SELF TAPPING SCREW
M697X0805530SDX1	5.5 X 30mm, IRIX-A, SELF DRILLING SCREW, CE MARKED
M697X0805530SD1	5.5 X 30mm, IRIX-A, SELF DRILLING SCREW
M697X0805525STX1	5.5 X 25mm, IRIX-A, SELF TAPPING SCREW, CE MARKED
M697X0805525ST1	5.5 X 25mm, IRIX-A, SELF TAPPING SCREW
M697X0805525SDX1	5.5 X 25mm, IRIX-A, SELF DRILLING SCREW, CE MARKED
M697X0805525SD1	5.5 X 25mm, IRIX-A, SELF DRILLING SCREW
M697X08042301912TPC1	IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 19mm, PC
M697X08042301912T1	IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 12°, 19mm
M697X08042301912STRX1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 19mm (STERILE), CE MARKED
M697X08042301912STR1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 19mm (STERILE)
M697X08042301912PCSTRX1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 19mm, PC (STERILE), CE MARKED
M697X08042301912PCSTR1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 19mm, PC (STERILE)
M697X08042301908TPC1	IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 8°, 19mm, PC
M697X08042301908T1	IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 8°, 19mm
M697X08042301908STRX1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 19mm (STERILE), CE MARKED
M697X08042301908STR1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 19mm (STERILE)
M697X08042301908PCSTRX1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 19mm, PC (STERILE), CE MARKED
M697X08042301908PCSTR1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 19mm, PC (STERILE)
M697X08042301712TPC1	IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 17mm, PC
M697X08042301712T1	IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 12°, 17mm
M697X08042301712STRX1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 17mm (STERILE), CE MARKED
M697X08042301712STR1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 17mm (STERILE)
M697X08042301712PCSTRX1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 17mm, PC (STERILE), CE MARKED
M697X08042301712PCSTR1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 17mm, PC (STERILE)
M697X08042301708TPC1	IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 8°, 17mm, PC
M697X08042301708T1	IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 8°, 17mm
M697X08042301708STRX1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 17mm (STERILE), CE MARKED
M697X08042301708STR1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 17mm (STERILE)
M697X08042301708PCSTRX1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 17mm, PC (STERILE), CE MARKED
M697X08042301708PCSTR1	IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 17mm, PC (STERILE)
M697X08042301512TPC1	IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 15mm, PC
M697X08042301512T1	IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 12°, 15mm

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