Xtant Medical provides quick and easy access to product literature online as well as printed documents for many products. Below you will find Instructions for Use (IFU) for selected products. Xtant Medical recommends that product IFUs be downloaded, printed, reviewed, and readily available for operator reference during procedures when using our devices.
Symbols Glossary
For explanation of the symbols on the packaging and labeling, see xtantmedical.com/resources/symbols-glossary
If you have difficulties accessing documents or would like to request a printed copy at no extra cost, please contact Xtant Medical Customer Service: CS@xtantmedical.com.
Biologics
3Demin IFU
Cancellous Crushed IFU
H-GRAFT IFU
Matriform Si IFU
OsteoSelect IFU
OsteoSelect Plus IFU
OsteoSponge IFU
OsteoWrap IFU
OsteoVive IFU
OsteoMax DBM Putty IFU
OsteoVive Plus IFU
OsteoFactor IFU
OsteoFactor Pro IFU
Amniotic Tissue IFU
nanOss 3D Plus IFU
nanOss and nanOss Loaded IFU
nanOss 3D IFU
Fixation
Aranax IFU
Atrix-C IFU
Axle/Axle-X IFU
Butrex IFU
Calix-C IFU
Calix Lumbar IFU
Certex IFU
CoFix IFU
Coflex IFU
Coflex/CoFix Instrument Reprocessing IFU
Fixcet IFU
Fortex IFU
InTice IFU
Irix-A IFU
Irix-C IFU
Silex IFU
Spider IFU
X90 IFU
Xpress IFU
Zyfix IFU
Surgalign
CervAlign® Anterior Cervical Plate System
Instructions for Use
United States:
European Union:
Product not available in the European Union
CoFix™ Posterior Fixation System
Instructions For Use
United States:
European Union:
Languages: EN, DE, FR, ES, IT, PT, NL, PL
Additional Countries: (Contact customer service for product availability)
Coflex® Interlaminar Technology
Instructions For Use
United States:
European Union:
Coflex Interlaminar Stablization Device
Languages: EN, DE, FR, ES, IT, PT, NL, EL, CS, PL, BG, LT, LV, SL, SK
Additional Countries: (Contact customer service for product availability)
Cortera™ Spinal Fixation System
Instructions for Use
United States:
European Union
Product not available in the European Union
DCI™ Dynamic Cervical Implant
Instructions For Use
United States:
Product not available in the United States
European Union:
Languages: EN, DE, FR, ES, IT, PT, NL, EL, CS, PL, BG, SK
Additional Countries: (Contact customer service for product availability)
DSS™ Stabilization System
United States:
Product not available in the United States
European Union:
DSS Stabilization System
Languages: EN, DE
Additional Countries: (Contact customer service for product availability)
DSS Stabilization System
Fortilink® IBF System with TiPlus™ Technology
Instructions For Use
United States:
European Union:
- For all EU Fortilink IBF System with TiPlus Technology IFUs, please visit Baat Medical.
Additional Countries: (Contact customer service for product availability)
For Fortilink with TiPlus Technology Instrument IFUs, please see Instruments Section below.
HPS® 2.0 Hybrid Performance System
Instructions for Use
United States:
Product not available in the United States
European Union:
Languages: EN, DE, FR, ES, IT, PT, NL, EL, CS, SK
Additional Countries: (Contact customer service for product availability)
Streamline MIS Spinal Fixation System
Instruments
Fortilink IBF System with TiPlus Technology Instruments
Instructions For Use
United States:
European Union:
Languages: EN, DA, DE, ES, FR, IT, NL, PL
Additional Countries: (Contact customer service for product availability)
General Instruments and Trays
Instructions For Use
Languages: EN, DE, FR, ES, IT, PT, NL, EL, CS, PL, BG, LT, LV, SL
Streamline MIS Spinal Fixation System
Instructions for Use
Patient Information Leaflets
Australia:
- Patient Information Leaflet – Fortilink® IBF System with TiPlus™ Technology
- Patient Information Leaflet – DSS™ Dynamic Stabilization System
- Patient Information Leaflet – HPS™ / HPS™ 2.0 Hybrid Performance System
- Patient Information Leaflet – Streamline® Fenestrated Spinal Fixation System
- Patient Information Leaflet – Coflex® Interlaminar Stabilization Device
Languages: EN
UDI Construction:
To compile a unique device identifies (UDI) for reusable, reprocessed devices, the device identifies (GTIN) may be ascertained by searching for the part number in the FDA GUDID at https://accessgudid.nlm.nih.gov/. The production identifier (e.g., lot number) may be found directly marked on the device.