The following data is part of a premarket notification filed by Sintea Biotech, Inc. with the FDA for Sintea Biotech Dsc/alf Spinal System, Dsc.xx.t5.xx, Alf.xx.t5.xx.
| Device ID | K070181 |
| 510k Number | K070181 |
| Device Name: | SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SINTEA BIOTECH, INC. 407 LINCOLN RD. SUITE 10L Miami Beach, FL 33139 |
| Contact | Gustavo A Rios |
| Correspondent | Gustavo A Rios SINTEA BIOTECH, INC. 407 LINCOLN RD. SUITE 10L Miami Beach, FL 33139 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-19 |
| Decision Date | 2007-04-18 |
| Summary: | summary |