Electronic Instructions For Use (eIFU)
Dear Customer, this website provides Instructions for Use (eIFU) documents for products offered by AMES Medical. If you require additional assistance, or to request a free printed or earlier version, please contact customer service through any of the contact means listed below:
Email: orders.amesmedical@ames.group
Phone: (+34) 936 561 400
A printed version of the Instructions for Use will be provided at the latest within 7 calendar days upon request to AMES Medical customer service.
In case of a revision related with a safety issue, a Field Safety Notice (FSN) will be released.
Instructions for Use should always be reviewed before using or implanting a device.
The IFU documents on this site are valid only on the date accessed or printed. Responsibility resides with the healthcare professional to print the IFU document on the day the product is intended to be used to ensure the most current IFU is referenced.
AMES Medical Instructions for Use documents are published in PDF format, which requires the free version of Adobe Reader or similar software. If you do not already have Adobe Reader, you can download it by clicking the ¨Get Adobe Reader¨ button.
OsteoSinter® EVANS and COTTON wedges and related accessories
To view and print the required eIFU (electronic Instructions for Use), please follow the next steps:
- Find the product´s catalogue number (REF) in the menu below. The REF can be found on the product label.
- Check the date of manufacture of the lot on the product label to find the applicable version of the eIFU.
This version of the eIFU applies to the products manufactured from date: 2026-08
P00200B1
P00201B1
P00202B1
P00203B1
P00204B1
P00205B1
P00206B1
P00207B1
P00208B1
P00209A1
P00210A1
P00211A1
This version of the eIFU applies to the products manufactured from date: 2026-08
P00200B1
P00201B1
P00202B1
P00203B1
P00204B1
P00205B1
P00206B1
P00207B1
P00208B1
P00209A1
P00210A1
P00211A1
This version of the eIFU applies to the products manufactured from date: 2026-08
P00200B1
P00201B1
P00202B1
P00203B1
P00204B1
P00205B1
P00206B1
P00207B1
P00208B1
This version of the eIFU applies to the products manufactured from date: 2026-08
P00300B1
P00301B1
P00302B1
P00303B1
P00304B1
P00305B1
This version of the eIFU applies to the products manufactured from date: 2026-08
P00300B1
P00301B1
P00302B1
P00303B1
P00304B1
P00305B1
This version of the eIFU applies to the products manufactured from date: 2026-08
P00300B1
P00301B1
P00302B1
P00303B1
P00304B1
P00305B1
This version of the eIFU applies to the products manufactured from date: 2026-08
P00401B1
This version of the eIFU applies to the products manufactured from date: 2026-08
P00401B1
This version of the eIFU applies to the products manufactured from date: 2026-08
P00401B1
This version of the eIFU applies to the products manufactured from date: 2026-08
P00413B1
This version of the eIFU applies to the products manufactured from date: 2026-08
P00413B1
This version of the eIFU applies to the products manufactured from date: 2026-08
P00413B1
List of all previous versions:
| International | US Market | Brasil Market |
|---|---|---|
| p00100_4.1.35-ifu_rev0 31-03-2025 | p00100_ifu_us_rev1 2025-06 | p00100_ifu_brasil_rev0 2026-04 |
| No previous versions available | p00100_ifu_us_rev0 2024-12 | No previous versions available |
Products with the eIFU symbol on the label will have IFUs available on this website.
Products with the IFU symbol (without the eIFU indicator) may not have all documentation electronically. Please refer to customer service for more information (orders.amesmedical@ames.group).
Consult electronic instructions for use.
Instructions for use are available in an electronic format at
www.ames-medical.net/ifus.
Consult instructions for use (paper format).
Countries outside of the EU that leverage the CE Mark may not allow an eIFU. In those cases, a paper IFU (outserted) will be provided even though the eIFU symbol is available on the packaging.
Europe: Summary of Safety and Clinical Performance (SSCP)
Select the pdf below to view or print the SSCP (english version) for implantable devices.
The SSCP will be available on the EUDAMED public website as soon as operative: https://ec.europa.eu/tools/eudamed.
You can request a copy of the Summary of Safety and Clinical Performance (SSCP) for implantable devices in your language by sending an email specifying which device and language to orders.amesmedical@ames.group.