The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Signus Sacronail® Transsacral Stabilization System.
| Device ID | K212755 |
| 510k Number | K212755 |
| Device Name: | SIGNUS SACRONAIL® Transsacral Stabilization System |
| Classification | Screw, Fixation, Bone |
| Applicant | SIGNUS Medizintechnik GmbH Industriestrasse 2 Alzenau, DE 63755 |
| Contact | Holger Noss |
| Correspondent | Carolyn Guthrie Kapstone Medical, LLC 520 Elliot St. Charlotte, NC 28202 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-31 |
| Decision Date | 2022-03-10 |