The following data is part of a premarket notification filed by Sintea Biotech, Inc. with the FDA for X-void, Spider.
| Device ID | K072198 |
| 510k Number | K072198 |
| Device Name: | X-VOID, SPIDER |
| Classification | Arthroscope |
| 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 | HRX |
| Subsequent Product Code | HXG |
| Subsequent Product Code | OAR |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-07 |
| Decision Date | 2008-06-06 |
| Summary: | summary |