Verte-Stack Spinal System
FDA 510(k) K062073 · Medtronic Sofamor Danek
510(k) numberK062073
Submission
- Device name
- Verte-Stack Spinal System
- Applicant
- Medtronic Sofamor Danek
Memphis, TN, US - Received
- July 21, 2006
- Decision date
- August 14, 2006
- 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
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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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| K230716 | Robotic Graft Delivery InstrumentsOLO · Traditional | 07/18/2023SE |
| K212428 | Centerpiece Plate Fixation SystemNQW · Traditional | 12/13/2021SE |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMAX · Traditional | 08/26/2020SE |
| K173125 | T2 STRATOSPHERE Expandable Corpectomy SystemMQP · Traditional | 12/20/2017SE |
| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…MAX · Traditional | 09/19/2017SE |
| K171031 | CRESCENT Spinal SystemMAX · Special | 07/06/2017SE |
| K171468 | FUSE Spinal SystemMAX · Special | 06/13/2017SE |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…NKB · Traditional | 05/11/2017SE |
Questions and answers
When was Verte-Stack Spinal System cleared by the FDA?
Verte-Stack Spinal System (K062073) received a 510(k) decision of Substantially Equivalent on August 14, 2006, 24 days after the submission was received.
What is the product code of K062073?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.