The following data is part of a premarket notification filed by Sintea Biotech, Inc. with the FDA for Sintea Biotech Schanz Screw, Model Tfx.ss.xx.x.
| Device ID | K031154 |
| 510k Number | K031154 |
| Device Name: | SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X |
| Classification | Pin, Fixation, Threaded |
| 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 | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-11 |
| Decision Date | 2003-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057432561649 | K031154 | 000 |
| 08057432561632 | K031154 | 000 |
| 08057432561625 | K031154 | 000 |
| 08057432561618 | K031154 | 000 |
| 08057432561601 | K031154 | 000 |
| 08057432561595 | K031154 | 000 |
| 08057432561588 | K031154 | 000 |
| 08057432561571 | K031154 | 000 |