Spinesmith Cimplicity Spinal System
FDA 510(k) K080971 · Spine Smith Partners L.P.
510(k) numberK080971
Submission
- Device name
- Spinesmith Cimplicity Spinal System
- Applicant
- Spine Smith Partners L.P.
Austin, TX, US - Received
- April 4, 2008
- Decision date
- July 2, 2008
- 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
Other 510(k)s with product code MQP
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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 |
More from Corelink, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K122630 | IN:C2 Spinal Fixation SystemOVE · Special | 12/05/2012SE |
| K122168 | Visualif Challenging Access PlateOVD · Special | 10/11/2012SE |
| K102090 | Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemOVD · Special | 09/30/2010SE |
| K101085 | Spinesmith Cynch Spinal SystemMAX · Special | 07/01/2010SE |
| K090376 | Spinesmith Cynch Spinal SystemMAX · Traditional | 04/01/2009SE |
| K082821 | Spinesmith Partners, LP Cequence Anterior Cervical Plate SystemKWQ · Traditional | 10/31/2008SE |
| K081132 | Spinesmith Partners, LP Cequence Anterior Cervical Plate SystemKWQ · Traditional | 07/14/2008SE |
| K073320 | Cimplicity Spinal SystemODP · Traditional | 02/07/2008SE |
Questions and answers
When was Spinesmith Cimplicity Spinal System cleared by the FDA?
Spinesmith Cimplicity Spinal System (K080971) received a 510(k) decision of Substantially Equivalent on July 2, 2008, 89 days after the submission was received.
What is the product code of K080971?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.