# Nuvasive Specialized Orthopedics, Inc.

- Location (FDA's records): Alisa Viejo, CA
- FDA decisions: 25 (2016–2026): 25 510(k) clearances
- Names in FDA's records: Nuvasive Specialized Orthopedics, Inc. (20); Nuvasive Specialized Orthopedics, Incorporated (4); NuVasive Specialized Orthopedics (1)
- Product codes: HSB (18), PGN (5), KTT (1), KCT (1)
- 510(k) review time since 2016: median 132 days, against 119 for FDA's reviews in the same codes and years (10 of 20 faster)
- Predicates its devices cite: 54 (31 its own); citations of its devices by later devices: 32 (31 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ellipse Technologies, Inc.: 19 (https://510kreport.com/company/ellipse-technologies)
- Inter-Os Technologies: 1 (https://510kreport.com/company/inter-os-technologies)
- OrthoPediatrics Corp.: 1 (https://510kreport.com/company/orthopediatrics)
- Wittenstein Intens GmbH: 1 (https://510kreport.com/company/wittenstein-intens)
- MedShape, Inc.: 1 (https://510kreport.com/company/medshape)

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

## Its most-cited devices
- K180503: PRECICE STRYDE System (2018), cited by 4
- K173129: PRECICE System (2017), cited by 3
- K172628: PRECICE System (2017), cited by 3
- K220234: Precice Intramedullary Limb Lengthening System (2023), cited by 3
- K161751: MAGEC® Spinal Bracing and Distraction System (2016), cited by 2
- K192181: PRECICE Plating System (2019), cited by 2

## Recent decisions
- K261651: Precice™ Max System and Precice™ Ankle Salvage System (Jun 18, 2026)
- K233593: MAGEC Spinal Bracing and Distraction System (Feb 6, 2024)
- K232267: Precice Max System (Dec 15, 2023)
- K230765: Precice Ankle Salvage System (Aug 29, 2023)
- K220234: Precice Intramedullary Limb Lengthening System (Mar 15, 2023)
- K202348: External Remote Controller ERC 4P (Dec 22, 2020)
- K200430: Precice® Ankle Salvage System (Sep 16, 2020)
- K201567: Precice® Bone Transport System (Aug 10, 2020)

Source page: https://510kreport.com/company/nuvasive-specialized-orthopedics