This website provides Instructions for Use (IFU) documents for products offered by SeaSpine Orthopedics Corporation. These prescription-use products are intended for use by healthcare professionals only. The IFU documents on this site are valid only on the date 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.
Clinical indications of products published on the SeaSpine Orthopedics Corporation website are subject to individual national regulatory authorization. The IFU documents on this site are only valid on the date accessed.
To view and print Instructions for Use, use the menu below to select the product and appropriate language. If you require additional assistance, or to request a hard copy of the Instructions for Use, please Contact Us.
Inventory Control Sheets
The FDA has required that all medical device manufacturers label their products with both production identification and device identification. This requirement is called Unique Device Identification, often abbreviated as UDI. To meet the UDI Point of Use requirement for non-sterile products SeaSpine allows you to create Inventory Control Sheets using information marked on the product. Inventory Control Sheets contain the product’s item number, item description and GTIN information. Inventory Control Sheets also provide entry fields to record the quantity and lot number of any non-sterile product that was used. To create Inventory Control Sheets, enter case and product information below. If you require additional assistance, please Contact Us.
The FDA has also created Global Unique Device Identification Database (GUDID) where medical device manufacturers can upload their products’ data which is accessible to the public. To view a SeaSpine Product on GUDID, Click Here.