Class Class II
Signus Tetris™ St; Signus Tetris™ R St (K241438)
Description
Signus Tetris™ St; Signus Tetris™ R St by Signus Medizintechnik GmbH, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241438
Clearance Date2024-09-11
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241438
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Signus Tetris™ St; Signus Tetris™ R St (K241438) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141405 | MOBIS II ST SPINAL IMPLANT | Signus Medizintechnik GmbH | 2014 |
| K123758 | TASMIN R | Signus Medizintechnik GmbH | 2014 |
| K122317 | TETRIS II | Signus Medizintechnik GmbH | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243188 | CYLOX® ST | Signus Medizintechnik GmbH | 2025 |
Trace the full predicate network for K241438
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.