# NanoHive Medical, LLC

- Location (FDA's records): Woburn, MA
- FDA decisions: 3 (2022–2026): 3 510(k) clearances
- Product codes: MAX (1), OVE (1), ODP (1)
- 510(k) review time since 2016: median 60 days, against 117 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 15 (1 its own); citations of its devices by later devices: 2 (1 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
- SeaSpine Orthopedics Corporation: 4 (https://510kreport.com/company/seaspine-orthopedics)
- Hd Lifesciences, LLC: 2 (https://510kreport.com/company/hd-lifesciences)
- Eit Emerging Implant Technologies GmbH: 1 (https://510kreport.com/company/eit-emerging-implant-technologies)
- L&K BIOMED Co., Ltd.: 1 (https://510kreport.com/company/l-k-biomed)
- MiRus, LLC: 1 (https://510kreport.com/company/mirus)
- Curiteva, Inc.: 1 (https://510kreport.com/company/curiteva)
- Eminent Spine: 1 (https://510kreport.com/company/eminent-spine)
- Elevation Spine: 1 (https://510kreport.com/company/elevation-spine)

## Firms that cite its devices most
- Carlsmed, Inc.: 1 (https://510kreport.com/company/carlsmed)

## Its most-cited devices
- K223190: Hive™ Standalone Cervical System (2022), cited by 2

## Recent decisions
- K254105: Hive™ Standalone Cervical System and Hive™ C Interbody System (Feb 13, 2026)
- K231241: NanoHive Medical Lumbar Interbody System (Jul 12, 2023)
- K223190: Hive™ Standalone Cervical System (Dec 12, 2022)

Source page: https://510kreport.com/company/nanohive-medical