Spacevision Cage System
FDA 510(k) K042930 · Spine Vision, Inc.
510(k) numberK042930
Submission
- Device name
- Spacevision Cage System
- Applicant
- Spine Vision, Inc.
Atlanta, GA, US - Received
- October 22, 2004
- Decision date
- December 28, 2004
- 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 |
|---|---|---|
| K052406 | Uni-Thread Spinal SystemMNI · Traditional | 11/07/2005SE |
| K030526 | Pediguard Nerve Detector SystemGWF · Traditional | 12/29/2004SE |
| K042640 | Uni-Thread Spinal SystemMNH · Traditional | 11/23/2004SE |
| K033508 | Plus Pivot Link Universal SystemMNI · Traditional | 01/27/2004SE |
| K032398 | Plus Pivot Link Universal SystemMNI · Traditional | 10/31/2003SE |
| K022271 | Plus Pivot Link Universal SystemMNI · Traditional | 09/23/2002SE |
| K021510 | Uni-T Uni-Thread Spinal SystemMNI · Traditional | 08/01/2002SE |
| K021507 | Plus Pivot Link Universal SystemKWP · Traditional | 08/01/2002SE |
| K013312 | P.L.U.S. System (Pivot Link Universal System)KWP · Traditional | 02/13/2002SE |
| K013301 | Uni-T Spinal SystemMNI · Traditional | 02/13/2002SE |
Questions and answers
When was Spacevision Cage System cleared by the FDA?
Spacevision Cage System (K042930) received a 510(k) decision of Substantially Equivalent on December 28, 2004, 67 days after the submission was received.
What is the product code of K042930?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.