510(k) K243802
- Device
- aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation
- Applicant
- Carlsmed, Inc.
- 510(k) number
- K243802
- Product code
- OVD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-17
- Date received
- 2024-12-11
- 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
Related Records
Applicant Contact
- Contact
- Karen Liu
- Address
- 1800 Aston Ave. Suite 100 Carlsbad CA US 92008 92008
FDA Registration Numbers
- 1423662
- 1450662
- 1000200989
- 3014967969
- 2133928
- 3005180920
- 3012131184
- 3013820501
- 3009241418
- 2530808
- 3006404071
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- 3010866843
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- 3026776
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- 3024999441
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- 3006272282
- 3019878714
- 2134285
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- 3013422238
- 3008262872
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810056991326 | aprevo | Carlsmed, Inc. | 2025-08-25 |
| 00810056993054 | aprevo® | Carlsmed, Inc. | 2025-07-04 |
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| 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 |
| 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 |
| K241077 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2024-10-29 |