Stackable Cage System
FDA 510(k) K001340 · Depuyacromed
510(k) numberK001340
Submission
- Device name
- Stackable Cage System
- Applicant
- Depuyacromed
Raynham, MA, US - Received
- April 27, 2000
- Decision date
- July 26, 2000
- 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 |
|---|---|---|
| K040197 | Eagle Anterior Cervial Plate SystemKWQ · Special | 04/02/2004SE |
| K031635 | Depuy Acromed VBR SystemMQP · Special | 06/23/2003SE |
| K030833 | Depuy Acromed VBR SystemMQP · Special | 04/10/2003SE |
| K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsMNH · Special | 02/26/2003SE |
| K030249 | Surgical Titanium Mesh SystemMQP · Special | 02/14/2003SE |
| K030103 | Summit Oct Spinal System Minipolyaxial ScrewsMNI · Special | 02/05/2003SE |
| K023835 | Devex Mesh SystemMQP · Special | 01/29/2003SE |
| K024348 | Monarch Spine SystemMNH · Special | 01/28/2003SE |
| K023804 | Moss Miami Spinal System Pin NutKWP · Special | 01/23/2003SE |
| K021039 | Bowti Anterior Buttress Staple SystemKWQ · Traditional | 12/11/2002SE |
Questions and answers
When was Stackable Cage System cleared by the FDA?
Stackable Cage System (K001340) received a 510(k) decision of Substantially Equivalent on July 26, 2000, 90 days after the submission was received.
What is the product code of K001340?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.