# Spirox, Inc.

- Location (FDA's records): Menlo Park, CA
- FDA decisions: 3 (2014–2016): 3 510(k) clearances
- Product codes: NHB (3)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 3 (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
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- ETHICON, Inc.: 1 (https://510kreport.com/company/ethicon)
- Macropore Biosurgery, Inc.: 1 (https://510kreport.com/company/macropore-biosurgery)
- Porex Surgical, Inc.: 1 (https://510kreport.com/company/porex-surgical)

## Firms that cite its devices most
- Spirair, Inc.: 1 (https://510kreport.com/company/spirair)
- Entellus Medical, Inc. (Aka Stryker Ent): 1 (https://510kreport.com/company/entellus-medical-aka-stryker-ent)

## Its most-cited devices
- K152958: INEX Absorbable Nasal Implant (2015), cited by 1
- K132920: Spirox Inex Device (2014), cited by 1
- K161191: Latera Absorbable Nasal Implant (2016), cited by 1

## Recent decisions
- K161191: Latera Absorbable Nasal Implant (Jun 23, 2016)
- K152958: INEX Absorbable Nasal Implant (Dec 4, 2015)
- K132920: Spirox Inex Device (Jun 10, 2014)

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