Camber Spine Technologies SPIRA - V Open Matrix Corpectomy Cage
FDA 510(k) K173800 · Camber Spine Technologies
510(k) numberK173800
Submission
- Device name
- Camber Spine Technologies SPIRA - V Open Matrix Corpectomy Cage
- Applicant
- Camber Spine Technologies
Wayne, PA, US - Received
- December 14, 2017
- Decision date
- February 2, 2018
- 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
| 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
| 510(k) | Device | Decision |
|---|---|---|
| K234077 | SPIRA® Anterior Lumbar SpacersMAX · Traditional | 07/12/2024SE |
| K232256 | Alcantara Thoracolumbar Plate SystemKWQ · Traditional | 04/16/2024SE |
| K233972 | Camber Sacroiliac (SI) Fixation SystemOUR · Traditional | 02/27/2024SE |
| K230942 | SPIRA® Posterior Lumbar SpacersMAX · Traditional | 07/11/2023SE |
| K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)OVD · Traditional | 03/30/2023SE |
| K223837 | SPIRA®-C Integrated Fixation SystemOVE · Traditional | 03/22/2023SE |
| K203503 | Camber Sacroiliac (SI) Fixation SystemOUR · Traditional | 09/02/2022SE |
| K220038 | Camber Spine Navigation SystemOLO · Traditional | 04/29/2022SE |
| K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersMAX · Traditional | 06/15/2021SE |
| K193153 | SPIRA-C Integrated Fixation SystemOVE · Traditional | 04/24/2020SE |
Questions and answers
When was Camber Spine Technologies SPIRA - V Open Matrix Corpectomy Cage cleared by the FDA?
Camber Spine Technologies SPIRA - V Open Matrix Corpectomy Cage (K173800) received a 510(k) decision of Substantially Equivalent on February 2, 2018, 50 days after the submission was received.
What is the product code of K173800?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.