# Hd Lifesciences, LLC

- Location (FDA's records): Stoneham, MA
- FDA decisions: 3 (2017–2020): 3 510(k) clearances
- Product codes: ODP (1), MAX (1), OVD (1)
- 510(k) review time since 2016: median 129 days, against 116 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 11 (2 its own); citations of its devices by later devices: 11 (2 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
- K2m, Inc.: 2 (https://510kreport.com/company/k2m)
- Synthes Spine: 2 (https://510kreport.com/company/synthes-spine)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Stryker Spine: 1 (https://510kreport.com/company/stryker-spine)
- Corelink, LLC: 1 (https://510kreport.com/company/corelink)
- Renovis Surgical Technologies, LLC: 1 (https://510kreport.com/company/renovis-surgical-technologies)
- Neurostructures, Inc.: 1 (https://510kreport.com/company/neurostructures)

## Firms that cite its devices most
- NanoHive Medical, LLC: 2 (https://510kreport.com/company/nanohive-medical)
- Titan Spine, LLC: 2 (https://510kreport.com/company/titan-spine)
- Nexus Spine, LLC: 2 (https://510kreport.com/company/nexus-spine)
- Printerprezz: 1 (https://510kreport.com/company/printerprezz)
- Aurora Spine, Inc.: 1 (https://510kreport.com/company/aurora-spine)
- Prism Surgical Designs Pty, Ltd.: 1 (https://510kreport.com/company/prism-surgical-designs)

## Its most-cited devices
- K170676: HD Lumbar Interbody System (2017), cited by 7
- K180364: HD LifeSciences Cervical IBFD System (2018), cited by 3
- K200541: Hive™ Stand-alone Anterior Lumbar Interbody System (2020), cited by 1

## Recent decisions
- K200541: Hive™ Stand-alone Anterior Lumbar Interbody System (Apr 28, 2020)
- K180364: HD LifeSciences Cervical IBFD System (Jun 27, 2018)
- K170676: HD Lumbar Interbody System (Jul 13, 2017)

Source page: https://510kreport.com/company/hd-lifesciences