510(k) K222009
- Device
- aprevo® anterior lumbar interbody fusion device with interfixation
- Applicant
- Carlsmed, Inc.
- 510(k) number
- K222009
- Product code
- OVD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-22
- Date received
- 2022-07-07
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Karen Liu
- Address
- 1800 Aston Ave. Suite 100 Carlsbad CA US 92008 92008
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00810056991425 | aprevo | Carlsmed, Inc. | 2024-04-02 |
| 00810056991388 | aprevo | Carlsmed, Inc. | 2024-04-02 |
| 00810056991463 | aprevo | Carlsmed, Inc. | 2024-04-02 |
| 00810056990039 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056990046 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056990084 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056990091 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056990138 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056990145 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056990183 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056990190 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991142 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991159 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991166 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991173 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991180 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991197 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991203 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991210 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991227 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991234 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991241 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991258 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991265 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991272 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991289 | aprevo | Carlsmed, Inc. | 2023-01-09 |
| 00810056991296 | aprevo | Carlsmed, Inc. | 2023-01-09 |
Other 510(k) Records For Product Code OVD
| 510(k) | Device | Applicant | Decision date |
|---|
| K254202 | MectaLIF 3D Metal Anterior | Medacta International S.A. | 2026-05-05 |
| K253401 | SCRIPT Implant System | Globus Medical, Inc. | 2026-04-29 |
| K253559 | Ventana A Anterior Lumbar Interbody System | Spinal Elements, Inc. | 2026-02-25 |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2025-12-08 |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | Alphatec Spine | 2025-09-03 |
| K250072 | CONDUIT SYNFIX Evolution Secured Spacer System | Avalign Technologies, Inc. | 2025-07-10 |
| K251644 | ProAM ALIF System | Pro Surgical, Inc. | 2025-06-24 |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2025-06-18 |
| K251459 | OneLIF Interbody Fusion System | Novapproach Spine, LLC | 2025-06-12 |
| K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | 2025-04-30 |
| K243386 | Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC | 2025-04-22 |
| K250603 | AxTiHA® Stand-Alone ALIF System | Innovasis | 2025-03-24 |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2025-03-17 |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024-12-13 |
| K243191 | Atlas Spine Lateral Expandable Interbody System | Atlas Spine, Inc. | 2024-11-26 |