# Sky Surgical, LLC

- Location (FDA's records): Sandpoint, ID
- FDA decisions: 1 (2023–2023): 1 510(k) clearance
- Product codes: HRS (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 1 (0 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
- Orthohelix Surgical Designs, Inc.: 1 (https://510kreport.com/company/orthohelix-surgical-designs)
- Additive Orthopaedics, LLC: 1 (https://510kreport.com/company/additive-orthopaedics)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Treace Medical Concepts, Inc.: 1 (https://510kreport.com/company/treace-medical-concepts)

## Firms that cite its devices most
- Met One Technologies, LLC: 1 (https://510kreport.com/company/met-one-technologies)

## Its most-cited devices
- K233154: SkyOPS™ Orthopedic Plate System (2023), cited by 1

## Recent decisions
- K233154: SkyOPS™ Orthopedic Plate System (Dec 21, 2023)

Source page: https://510kreport.com/company/sky-surgical