Ascend VBR System, Ascend NanoTec VBR System
FDA 510(k) K232173 · Alphatec Spine, Inc.
510(k) numberK232173
Submission
- Device name
- Ascend VBR System, Ascend NanoTec VBR System
- Applicant
- Alphatec Spine, Inc.
Carlsbad, CA, US - Received
- July 21, 2023
- Decision date
- October 6, 2023
- 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 |
| 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 |
| K200235 | KONG-TL VBR System, KONG-C VBR SystemMQP · Traditional | Icotec AG | 05/29/2020SE |
More from Icotec AG
| 510(k) | Device | Decision |
|---|---|---|
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional | 07/14/2026SE |
| K253216 | IntraOp Alignment System; CONTOUR3D Bending SystemSIN · Traditional | 06/25/2026SE |
| K253615 | Invictus Bands SystemOWI · Traditional | 03/25/2026SE |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…OLO · Traditional | 02/19/2026SE |
| K252842 | SafeOp 3: Neural Informatix SystemGWF · Traditional | 01/11/2026SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | 09/03/2025SE |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ · Traditional | 08/28/2025SE |
| K251080 | IdentiTi II Cervical Interbody SystemODP · Traditional | 07/03/2025SE |
| K243461 | Calibrate Interbody Systems · Traditional | 03/04/2025SE |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…MAX · Traditional | 02/03/2025SE |
Questions and answers
When was Ascend VBR System, Ascend NanoTec VBR System cleared by the FDA?
Ascend VBR System, Ascend NanoTec VBR System (K232173) received a 510(k) decision of Substantially Equivalent on October 6, 2023, 77 days after the submission was received.
What is the product code of K232173?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.