Santorini Spinal System
FDA 510(k) K111294 · K2m, Inc.
510(k) numberK111294
Submission
- Device name
- Santorini Spinal System
- Applicant
- K2m, Inc.
Leesburg, VA, US - Received
- May 10, 2011
- Decision date
- January 27, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
| 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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| K253545 | Vulcan Spinal SystemNKB · Traditional | 02/10/2026SE |
| K252873 | Q Interbody InstrumentsOLO · Traditional | 02/06/2026SE |
| K211320 | CAPRI Corpectomy Cage SystemPLR · Traditional | 02/24/2022SE |
| K202528 | Cannulated Power Driver AttachmentNKB · Traditional | 10/26/2020SE |
| K201006 | K2M Navigation InstrumentsOLO · Special | 08/07/2020SE |
| K193203 | MOJAVE Expandable Interbody SystemMAX · Special | 02/18/2020SE |
| K193129 | Yukon OCT Spinal SystemNKG · Traditional | 02/07/2020SE |
| K192911 | Brainlab Compatible K2M Navigation InstrumentsOLO · Special | 11/14/2019SE |
| K190179 | SAHARA Stabilization SystemOVD · Traditional | 10/03/2019SE |
Questions and answers
When was Santorini Spinal System cleared by the FDA?
Santorini Spinal System (K111294) received a 510(k) decision of Substantially Equivalent on January 27, 2012, 262 days after the submission was received.
What is the product code of K111294?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.