# Carlsmed, Inc.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 23 (2020–2026): 23 510(k) clearances
- Names in FDA's records: Carlsmed, Inc. (22); Carlsmed (1)
- Product codes: MAX (11), OVD (4), KWQ (3), LLZ (2), ODP (2), QIH (1)
- 510(k) review time since 2016: median 111 days, against 95 for FDA's reviews in the same codes and years (9 of 23 faster)
- Predicates its devices cite: 60 (36 its own); citations of its devices by later devices: 39 (36 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Globus Medical, Inc.: 4 (https://510kreport.com/company/globus-medical)
- Medicrea International SA: 3 (https://510kreport.com/company/medicrea-international)
- Alphatec Spine, Inc.: 3 (https://510kreport.com/company/alphatec-spine)
- SeaSpine Orthopedics Corporation: 2 (https://510kreport.com/company/seaspine-orthopedics)
- Materialise NV: 2 (https://510kreport.com/company/materialise)
- Nvision Biomedical Technologies, Inc.: 1 (https://510kreport.com/company/nvision-biomedical-technologies)
- Nexxt Spine, LLC: 1 (https://510kreport.com/company/nexxt-spine)
- Pioneer Surgical Technology: 1 (https://510kreport.com/company/pioneer-surgical-technology)

## Firms that cite its devices most
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Agada Medical, Ltd.: 1 (https://510kreport.com/company/agada-medical)

## Its most-cited devices
- K222082: aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices (2022), cited by 6
- K202034: aprevo Intervertebral Body Fusion Device (2020), cited by 5
- K222009: aprevo® anterior lumbar interbody fusion device with interfixation (2022), cited by 5
- K241332: aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device (2024), cited by 3
- K252611: aprevo® cervical plating system (2025), cited by 2
- K250827: 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 (2025), cited by 2

## Recent decisions
- K262149: corra® cervical plating system (Sep 24, 2026)
- K260385: aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system (May 9, 2026)
- K260570: corra™ cervical plating system (Apr 22, 2026)
- K252894: aprevo® cervical interbody system (Jan 6, 2026)
- K252611: aprevo® cervical plating system (Dec 22, 2025)
- K250827: 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 (Jul 7, 2025)
- K250987: aprevo® posterior/transforaminal lumbar interbody fusion device (Jun 30, 2025)
- K243802: aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation (Mar 17, 2025)

Source page: https://510kreport.com/company/carlsmed