Signus Tetris St; Signus Tetris R St
FDA 510(k) K241438 · Signus Medizintechnik GmbH
510(k) numberK241438
Submission
- Device name
- Signus Tetris St; Signus Tetris R St
- Applicant
- Signus Medizintechnik GmbH
Alzenau, DE - Received
- May 21, 2024
- Decision date
- September 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
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| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K243188 | Cylox® STOVE · Traditional | 02/11/2025SE |
| K220658 | COSY Cervicothoracic Occipital Rod-Screw SystemNKG · Traditional | 11/18/2022SE |
| K212755 | SIGNUS SACRONAIL® Transsacral Stabilization SystemHWC · Traditional | 03/10/2022SE |
| K203327 | VERTACONNECT TLIF CageMAX · Traditional | 01/25/2021SE |
| K151704 | Diplomat® Spinal SystemNKB · Traditional | 04/13/2016SE |
| K141405 | Mobis II ST Spinal ImplantMAX · Traditional | 09/16/2014SE |
| K123758 | Tasmin RMQP · Traditional | 01/14/2014SE |
| K131372 | Mobis IIMAX · Traditional | 07/02/2013SE |
| K122317 | Tetris IIMAX · Special | 08/29/2012SE |
| K111792 | Mobis, Moval, Semial, Tetrismodel PEEK and Titanium, Kimba Model Standard and MiniMAX · Traditional | 03/05/2012SE |
Questions and answers
When was Signus Tetris St; Signus Tetris R St cleared by the FDA?
Signus Tetris St; Signus Tetris R St (K241438) received a 510(k) decision of Substantially Equivalent on September 11, 2024, 113 days after the submission was received.
What is the product code of K241438?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.