Arx Spinal System
FDA 510(k) K051525 · Amedica Corp.
510(k) numberK051525
Submission
- Device name
- Arx Spinal System
- Applicant
- Amedica Corp.
Salt Lake City, UT, US - Received
- June 8, 2005
- Decision date
- February 17, 2006
- 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 |
|---|---|---|
| K173453 | Valeo® C+CSC with Lumen Interbody Fusion DeviceODP · Traditional | 03/05/2018SE |
| K162160 | Preference Elite Pedicle Screw SystemNKB · Traditional | 11/18/2016SE |
| K161405 | Valeo II Interbody Fusion Device SystemMAX · Special | 08/19/2016SE |
| K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device SystemMAX · Traditional | 10/02/2015SE |
| K142264 | Valeo C Spacer System, Valeo II C IBF DeviceODP · Traditional | 12/08/2014SE |
| K142347 | Amedica Valeo II Interbody Fusion DeviceMAX · Traditional | 11/18/2014SE |
| K121892 | Phantom Plus Ceramic Cage SystemMAX · Special | 08/24/2012SE |
| K091278 | Valeo Spacer SystemMAX · Traditional | 01/28/2010SE |
| K082037 | Seeplate Cervical Plate SystemKWQ · Special | 09/26/2008SE |
| K073430 | Valeo Pedicle Screw Spinal SystemNKB · Traditional | 01/29/2008SE |
Questions and answers
When was Arx Spinal System cleared by the FDA?
Arx Spinal System (K051525) received a 510(k) decision of Substantially Equivalent on February 17, 2006, 254 days after the submission was received.
What is the product code of K051525?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.