Irix-C Cervical Integrated Fusion System

GUDID M697X0663516SD1

3.5mm x 16 mm IRIX-C, SELF-DRILLING SCREW

Xtant Medical Holdings, Inc.

Spinal bone screw, non-bioabsorbable
Primary Device IDM697X0663516SD1
NIH Device Record Key6d8d991b-1056-45b2-a849-a477892eb956
Commercial Distribution StatusIn Commercial Distribution
Brand NameIrix-C Cervical Integrated Fusion System
Version Model NumberX066-3516SD
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com
Phone888-886-9354
Emailcs@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697X0663516SD1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697X0663516SD1]

Moist Heat or Steam Sterilization

[M697X0663516SD1]

Moist Heat or Steam Sterilization

[M697X0663516SD1]

Moist Heat or Steam Sterilization

[M697X0663516SD1]

Moist Heat or Steam Sterilization

[M697X0663516SD1]

Moist Heat or Steam Sterilization

[M697X0663516SD1]

Moist Heat or Steam Sterilization

[M697X0663516SD1]

Moist Heat or Steam Sterilization

[M697X0663516SD1]

Moist Heat or Steam Sterilization

[M697X0663516SD1]

Moist Heat or Steam Sterilization

[M697X0663516SD1]

Moist Heat or Steam Sterilization

[M697X0663516SD1]

Moist Heat or Steam Sterilization

[M697X0663516SD1]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-27
Device Publish Date2025-08-19

On-Brand Devices [Irix-C Cervical Integrated Fusion System]

M697C0660121060 Degree Fixed Angle Awl
M697C06601200Specialty Freehand Irix C Universal Joint Driver
M697C06601190Specialty Self Centering Bent Awl
M697C06601180Specialty Driver Tip
M697C06601070Specialty Irix C Trial 4mm Assembly
M697C066004207/8mm Double End 16 x 13 Lordotic Trial Assy
M697C06601321Special Irix-C Screwdriver Assembly
M697X066372113.7 X 21mm, IRIX-C, RESCUE SCREW
M697X066371913.7 X 19mm, IRIX-C, RESCUE SCREW
M697X066371713.7 X 17mm, IRIX-C, RESCUE SCREW
M697X066371513.7 X 15mm, IRIX-C, RESCUE SCREW
M697X066371313.7 X 13mm, IRIX-C, RESCUE SCREW
M697X0663520ST13.5mm x 20 mm IRIX-C, SELF-TAPPING SCREW
M697X0663520SD13.5mm x 20 mm IRIX-C, SELF-DRILLING SCREW
M697X0663518ST13.5mm x 18 mm IRIX-C, SELF-TAPPING SCREW
M697X0663516ST13.5mm x 16 mm IRIX-C, SELF-TAPPING SCREW
M697X0663516SD13.5mm x 16 mm IRIX-C, SELF-DRILLING SCREW
M697X0663514ST13.5mm x 14 mm IRIX-C, SELF-TAPPING SCREW
M697X0663514SD13.5mm x 14 mm IRIX-C, SELF-DRILLING SCREW
M697X0663512ST13.5mm x 12 mm IRIX-C, SELF-TAPPING SCREW
M697X0663512SD13.5mm x 12 mm IRIX-C, SELF-DRILLING SCREW
M697X06600070Instrument Sterilization Case II, lrix-C
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