Nuvasive Coroent Extensure System
FDA 510(k) K052210 · Nuvasive, Inc.
510(k) numberK052210
Submission
- Device name
- Nuvasive Coroent Extensure System
- Applicant
- Nuvasive, Inc.
San Diego, CA, US - Received
- August 15, 2005
- Decision date
- December 12, 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 |
More from Corelink, LLC
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| K233706 | Bendini Cloud ApplicationOLO · Traditional | 08/02/2024SE |
| K240507 | NuVasive AttraX ScaffoldMQV · Special | 03/20/2024SE |
| K223731 | NuVasive Modulus-C Interbody SystemODP · Special | 01/12/2023SE |
| K211757 | Simplify DiscQLQ · Traditional | 08/20/2021SE |
| K173117 | NuVasive® VersaTie SystemOWI · Traditional | 12/07/2017SE |
| K141665 | NuVasive CoRoent SystemMAX · Traditional | 03/13/2015SE |
| K142205 | NuVasive X-CORE(R) Expandable VBR SystemMQP · Traditional | 02/20/2015SE |
| K141968 | Nuvasive NVM5 SystemPDQ · Traditional | 11/14/2014SE |
| K140319 | Coroent Ti-C SystemMAX · Traditional | 10/09/2014SE |
| K140162 | Ap Expandable Xlif SystemMAX · Traditional | 07/02/2014SE |
Questions and answers
When was Nuvasive Coroent Extensure System cleared by the FDA?
Nuvasive Coroent Extensure System (K052210) received a 510(k) decision of Substantially Equivalent on December 12, 2005, 119 days after the submission was received.
What is the product code of K052210?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.