Bengal Stackable Cage System
FDA 510(k) K073649 · Depuy Spine, Inc.
510(k) numberK073649
Submission
- Device name
- Bengal Stackable Cage System
- Applicant
- Depuy Spine, Inc.
Raynham, MA, US - Received
- December 26, 2007
- Decision date
- January 25, 2008
- 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
| 510(k) | Device | Decision |
|---|---|---|
| K222276 | CONDUIT Cages; FIBERGRAFT BG PuttyODP · Traditional | 10/15/2022SE |
| K201831 | CONFIDENCE Spinal Cement SystemNDN · Traditional | 08/31/2020SE |
| K142185 | Expedium Verse Spine SystemNKB · Traditional | 11/19/2014SE |
| K111136 | Expedium Spine System, Viper System, Viper 2 SystemNKB · Traditional | 06/14/2012SESU |
| K121020 | Viper SystemNKB · Special | 05/03/2012SE |
| K110353 | Mountaineer Oct Spinal SystemKWP · Special | 04/07/2011SE |
| K110216 | Expedium System, Viper SystemNKB · Special | 04/01/2011SE |
| K103133 | Veper System, Expedium SystemNKB · Special | 01/18/2011SE |
| K101993 | Viper System, Expedium SystemNKB · Special | 12/07/2010SE |
| K101923 | Concorde Curve SystemMAX · Special | 12/01/2010SE |
Questions and answers
When was Bengal Stackable Cage System cleared by the FDA?
Bengal Stackable Cage System (K073649) received a 510(k) decision of Substantially Equivalent on January 25, 2008, 30 days after the submission was received.
What is the product code of K073649?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.