Semial Spinal Implant
FDA 510(k) K051659 · Signus Medizintechnik GmbH
510(k) numberK051659
Submission
- Device name
- Semial Spinal Implant
- Applicant
- Signus Medizintechnik GmbH
Minneapolis, MN, US - Received
- June 22, 2005
- Decision date
- July 13, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
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| 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 |
Questions and answers
When was Semial Spinal Implant cleared by the FDA?
Semial Spinal Implant (K051659) received a 510(k) decision of Substantially Equivalent on July 13, 2005, 21 days after the submission was received.
What is the product code of K051659?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.