Atlas Spine Vertebral Body Replacement
FDA 510(k) K063464 · Atlas Spine, Inc.
510(k) numberK063464
Submission
- Device name
- Atlas Spine Vertebral Body Replacement
- Applicant
- Atlas Spine, Inc.
Jupiter, FL, US - Received
- November 16, 2006
- Decision date
- March 9, 2007
- 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 |
|---|---|---|
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy ImplantPLR · Traditional | 07/15/2026SE |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy SystemPLR · Traditional | 11/10/2025SE |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody SystemMAX · Traditional | 08/15/2025SE |
| K243191 | Atlas Spine Lateral Expandable Interbody SystemOVD · Traditional | 11/26/2024SE |
| K202302 | Atlas Spine Rebar (Ti) Spacer SystemODP · Traditional | 10/30/2020SE |
| K192570 | Atlas Spine Expandable Cervical Standalone Interbody SystemOVE · Traditional | 02/28/2020SE |
| K182418 | V3 Segmental Plating SystemKWQ · Traditional | 11/29/2018SE |
| K180675 | Atlas Spine Expandable Cervical Interbody SystemODP · Traditional | 06/13/2018SE |
| K172334 | Ortus Expandable Lumbar Interbody Fusion SystemMAX · Traditional | 10/25/2017SE |
| K162918 | Atlas Spine Expandable Interbody SystemMAX · Traditional | 02/09/2017SE |
Questions and answers
When was Atlas Spine Vertebral Body Replacement cleared by the FDA?
Atlas Spine Vertebral Body Replacement (K063464) received a 510(k) decision of Substantially Equivalent on March 9, 2007, 113 days after the submission was received.
What is the product code of K063464?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.