Device Listing 1301764113

Listing Summary#

Listing key
1301764113
Premarket submission
K250827
Device
aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams
Applicant
Carlsmed, Inc.
Product code
MAX
Decision date
2025-07-07