aprevo® anterior and lateral lumbar interbody system +3 more— 510(k) K260385
Substantially EquivalentCarlsmed, Inc.
FDA 510(k) clearance K260385 for aprevo® anterior and lateral lumbar interbody system +3 more, Substantially Equivalent on 2026-05-09. Applicant: Carlsmed, Inc.. Device class: 2.
Summary
Carlsmed's record covers four systems: the aprevo anterior and lateral lumbar interbody system, the aprevo posterior and transforaminal lumbar interbody system, the aprevo cervical interbody system, and the corra cervical plating system. The record lists one product code: MAX, lumbar intervertebral fusion devices with bone graft.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. The submission was a Traditional 510(k).
Carlsmed filed from Carlsbad, California. The decision came 92 calendar days after receipt (February 6 to May 9, 2026).
Clearance details
- Device name as filed
- aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
- Applicant
- Carlsmed, Inc.
- Product code
- Product code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code MAX
view allMore clearances from Carlsmed, Inc.
view allAdverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.