The following data is part of a premarket notification filed by Sintea Biotech, Inc. with the FDA for Laki Hand Fixation System, Model Tfx.3x.06.x.
| Device ID | K082679 |
| 510k Number | K082679 |
| Device Name: | LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X |
| Classification | Component, Traction, Invasive |
| 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 | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-15 |
| Decision Date | 2009-04-07 |
| Summary: | summary |