aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices
FDA 510(k) K222082 · Carlsmed, Inc.
510(k) numberK222082
Submission
- Device name
- aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices
- Applicant
- Carlsmed, Inc.
Carlsbad, CA, US - Received
- July 15, 2022
- Decision date
- August 12, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code MAX
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|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
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| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…MAX · Traditional | 05/09/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | 04/22/2026SE |
| K252894 | aprevo® cervical interbody systemODP · Traditional | 01/06/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | 12/22/2025SE |
| K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…MAX · Traditional | 07/07/2025SE |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion deviceMAX · Traditional | 06/30/2025SE |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…OVD · Traditional | 03/17/2025SE |
| K242599 | aprevo® Digital PlanningLLZ · Traditional | 12/20/2024SE |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixationOVD · Special | 12/13/2024SE |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMODP · Traditional | 11/15/2024SE |
Questions and answers
When was aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices cleared by the FDA?
aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices (K222082) received a 510(k) decision of Substantially Equivalent on August 12, 2022, 28 days after the submission was received.
What is the product code of K222082?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.