The following data is part of a premarket notification filed by Stuckenbrock Medizintechnik Gmbh with the FDA for Hbs2 Headless Bone Screw.
| Device ID | K171628 |
| 510k Number | K171628 |
| Device Name: | HBS2 Headless Bone Screw |
| Classification | Screw, Fixation, Bone |
| Applicant | Stuckenbrock Medizintechnik GmbH Lessingstraße 50 Tuttlingen, DE D-78532 |
| Contact | Fabian Stuckenbrock |
| Correspondent | Fabian Stuckenbrock Stuckenbrock Medizintechnik GmbH Lessingstrasse 50 Tuttlingen, DE D-78532 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-02 |
| Decision Date | 2018-01-12 |
| Summary: | summary |