The following data is part of a premarket notification filed by Sintea Biotech, Inc. with the FDA for Sintea Biotech Pls Multi-axial Screws.
| Device ID | K081631 |
| 510k Number | K081631 |
| Device Name: | SINTEA BIOTECH PLS MULTI-AXIAL SCREWS |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SINTEA BIOTECH, INC. 407 LINCOLN RD. SUITE 10L Miami Beach, FL 33139 |
| Contact | Danielle Wernikowski |
| Correspondent | Danielle Wernikowski SINTEA BIOTECH, INC. 407 LINCOLN RD. SUITE 10L Miami Beach, FL 33139 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-11 |
| Decision Date | 2008-07-18 |
| Summary: | summary |