# Neurostructures, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 19 (2012–2020): 19 510(k) clearances
- Names in FDA's records: Neurostructures, Inc. (15); Neurostructures, LLC (3); Neurostructures (1)
- Product codes: KWQ (6), MAX (3), ODP (3), OVD (3), OVE (2), NKB (1), MRW (1)
- 510(k) review time since 2016: median 115 days, against 119 for FDA's reviews in the same codes and years (6 of 14 faster)
- Predicates its devices cite: 71 (18 its own); citations of its devices by later devices: 29 (18 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
- Blackstone Medical, Inc.: 5 (https://510kreport.com/company/blackstone-medical)
- Coalign Innovations, Inc.: 3 (https://510kreport.com/company/coalign-innovations)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Ldr Spine USA: 3 (https://510kreport.com/company/ldr-spine-usa)
- Synthes Spine: 2 (https://510kreport.com/company/synthes-spine)
- Orthofix, Inc.: 2 (https://510kreport.com/company/orthofix)
- Renovis Surgical Technologies, LLC: 2 (https://510kreport.com/company/renovis-surgical-technologies)
- Centinel Spine, Inc.: 2 (https://510kreport.com/company/centinel-spine)

## Firms that cite its devices most
- Precision Spine, Inc.: 2 (https://510kreport.com/company/precision-spine)
- Eminent Spine: 2 (https://510kreport.com/company/eminent-spine)
- Kyocera Medical Technologies, Inc.: 1 (https://510kreport.com/company/kyocera-medical-technologies)
- U&I Corporation: 1 (https://510kreport.com/company/u-i)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Orthopaedic & Spine Development: 1 (https://510kreport.com/company/orthopaedic-spine-development)
- SeaSpine Orthopedics Corporation: 1 (https://510kreport.com/company/seaspine-orthopedics)
- Hd Lifesciences, LLC: 1 (https://510kreport.com/company/hd-lifesciences)

## Its most-cited devices
- K120515: Tempus Cervical Plate System (2012), cited by 4
- K131374: Tempus (TM) Cervical Plate System (2013), cited by 4
- K173077: Cavetto-SA Cervical Cage System (2018), cited by 4
- K173082: Arco™-SA Lumbar Cage System (2018), cited by 3
- K172320: Neurostructures Cavetto® Cervical Cage System (2018), cited by 3
- K142060: Transom Anterior Cervical Plate (2014), cited by 3

## Recent decisions
- K202190: Oculus-SA Lumbar Cage System (Oct 2, 2020)
- K200115: Cavetto-SA Cervical Cage System (Sep 24, 2020)
- K201769: Cavetto [MAX] Cervical Cage System (Sep 3, 2020)
- K200927: Transept Cervical Plate System (Jul 24, 2020)
- K192248: Cortina™ [MAX] Lumbar Cage System (Nov 25, 2019)
- K182195: Arco™-SA Lumbar Cage System (Nov 9, 2018)
- K181590: Neurostructures Cavetto® [MAX] Cervical Cage System (Nov 8, 2018)
- K173082: Arco™-SA Lumbar Cage System (Mar 29, 2018)

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