# Neoortho Produtos Ortopedicos S/A

- Location (FDA's records): San Diego, CA
- FDA decisions: 6 (2010–2022): 6 510(k) clearances
- Names in FDA's records: Neoortho Produtos Ortopedicos S/A (5); Neoortho Produtos Ortopédicos S/A (1)
- Product codes: HSB (2), HRS (1), JEY (1), MAX (1), HWC (1)
- Predicates its devices cite: 37 (1 its own); citations of its devices by later devices: 5 (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): 20 (https://510kreport.com/company/synthes-usa)
- Howmedica Osteonics Corp.: 3 (https://510kreport.com/company/howmedica-osteonics)
- Stryker Trauma AG: 2 (https://510kreport.com/company/stryker-trauma)
- Walter Lorenz Surgical, Inc.: 2 (https://510kreport.com/company/walter-lorenz-surgical)
- Acu Med, Inc.: 1 (https://510kreport.com/company/acu-med)
- Acumed, LLC: 1 (https://510kreport.com/company/acumed)
- DePuy Orthopaedics, Inc.: 1 (https://510kreport.com/company/depuy-orthopaedics)
- Synthes: 1 (https://510kreport.com/company/synthes)

## Firms that cite its devices most
- Neoortho Productos Orthopedicos S/A: 2 (https://510kreport.com/company/neoortho-productos-orthopedicos-s-a)
- Visionare, LLC: 1 (https://510kreport.com/company/visionare)
- Orthonovis, Inc.: 1 (https://510kreport.com/company/orthonovis)

## Its most-cited devices
- K113733: Small and Large Fragments Osteosynthesis System Neofix (2012), cited by 2
- K102641: Mini and  Micro Fragments Reconstruction System-Neoface (2010), cited by 2
- K141103: Intramedullary Nail and Screws-Neonail (2014), cited by 1

## Recent decisions
- K221021: Femoral Trochanteric Nail System – Neonail (Dec 6, 2022)
- K162874: Cannulated Screws Neoortho (Jun 27, 2017)
- K141103: Intramedullary Nail and Screws-Neonail (Sep 23, 2014)
- K132852: Peek Cage for the Vertebral Spine (May 29, 2014)
- K113733: Small and Large Fragments Osteosynthesis System Neofix (Mar 23, 2012)
- K102641: Mini and  Micro Fragments Reconstruction System-Neoface (Dec 20, 2010)

Source page: https://510kreport.com/company/neoortho-produtos-ortopedicos-s-a