The following data is part of a premarket notification filed by Treu-instrumente Gmbh with the FDA for Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins.
| Device ID | K083912 |
| 510k Number | K083912 |
| Device Name: | TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS |
| Classification | Screw, Fixation, Bone |
| Applicant | TREU-INSTRUMENTE GMBH GRIESWEG 47 Muhlheim, Baden-wurttemberg, DE 78570 |
| Contact | Franz Menean |
| Correspondent | Franz Menean TREU-INSTRUMENTE GMBH GRIESWEG 47 Muhlheim, Baden-wurttemberg, DE 78570 |
| Product Code | HWC |
| Subsequent Product Code | HTY |
| Subsequent Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-30 |
| Decision Date | 2009-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10649111083877 | K083912 | 000 |
| 04048447333820 | K083912 | 000 |
| 04048447333813 | K083912 | 000 |
| 04048447299478 | K083912 | 000 |
| 04048447285822 | K083912 | 000 |
| 04048447257867 | K083912 | 000 |
| 04048447257676 | K083912 | 000 |
| 04048447219117 | K083912 | 000 |
| 04048447206230 | K083912 | 000 |
| 04048447045587 | K083912 | 000 |
| 04048447028900 | K083912 | 000 |
| 04048447028757 | K083912 | 000 |
| 04048447028177 | K083912 | 000 |
| 04048447028160 | K083912 | 000 |
| 04048447028153 | K083912 | 000 |
| 04048447333837 | K083912 | 000 |
| 04048447333844 | K083912 | 000 |
| 10649111083532 | K083912 | 000 |
| 10649111083303 | K083912 | 000 |
| 10649111083204 | K083912 | 000 |
| 10649111083082 | K083912 | 000 |
| 10649111082979 | K083912 | 000 |
| 10649111083716 | K083912 | 000 |
| 04048447333929 | K083912 | 000 |
| 04048447333912 | K083912 | 000 |
| 04048447333905 | K083912 | 000 |
| 04048447333899 | K083912 | 000 |
| 04048447333882 | K083912 | 000 |
| 04048447333875 | K083912 | 000 |
| 04048447333868 | K083912 | 000 |
| 04048447333851 | K083912 | 000 |
| 04048447018437 | K083912 | 000 |