The following data is part of a premarket notification filed by Sintea Biotech, Inc. with the FDA for Sintea Biotech Traumafix System, Model Tfx.00.00.x.
| Device ID | K022065 |
| 510k Number | K022065 |
| Device Name: | SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X |
| Classification | Component, Traction, Invasive |
| Applicant | SINTEA BIOTECH, INC. 407 LINCOLN RD. SUITE 10L Miami Beach, FL 33139 |
| Contact | Marianne Grunwaldt |
| Correspondent | Marianne Grunwaldt SINTEA BIOTECH, INC. 407 LINCOLN RD. SUITE 10L Miami Beach, FL 33139 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-25 |
| Decision Date | 2002-08-06 |
| Summary: | summary |