# Astura Medical

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 29 (2016–2026): 29 510(k) clearances
- Names in FDA's records: Astura Medical (21); Astura Medical, LLC (8)
- Product codes: MAX (7), NKB (5), OLO (3), OVD (3), ODP (2), PLR (1), KWQ (1), OWI (1), MQP (1), OUR (1), PML (1), NKG (1)
- 510(k) review time since 2016: median 149 days, against 102 for FDA's reviews in the same codes and years (6 of 26 faster)
- Predicates its devices cite: 139 (44 its own); citations of its devices by later devices: 71 (44 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
- Globus Medical, Inc.: 12 (https://510kreport.com/company/globus-medical)
- Medtronic Sofamor Danek USA, Inc.: 10 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Spinal Elements, Inc.: 8 (https://510kreport.com/company/spinal-elements)
- Depuy Spine, Inc.: 5 (https://510kreport.com/company/depuy-spine)
- Synthes Spine: 5 (https://510kreport.com/company/synthes-spine)
- Nu Vasive, Incorporated: 5 (https://510kreport.com/company/nu-vasive)
- Stryker Spine: 4 (https://510kreport.com/company/stryker-spine)
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)

## Firms that cite its devices most
- Pro Surgical, Inc.: 3 (https://510kreport.com/company/pro-surgical)
- Degen Medical: 2 (https://510kreport.com/company/degen-medical)
- Life Spine, Inc.: 2 (https://510kreport.com/company/life-spine)
- L&K BIOMED Co., Ltd.: 2 (https://510kreport.com/company/l-k-biomed)
- Corelink, LLC: 2 (https://510kreport.com/company/corelink)
- Xenco Medical, LLC: 1 (https://510kreport.com/company/xenco-medical)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)
- Additive Implants, Inc.: 1 (https://510kreport.com/company/additive-implants)

## Its most-cited devices
- K152512: Half Dome Posterior Lumbar Interbody System (2016), cited by 8
- K182877: HALF DOME Posterior Lumbar Interbody System (2019), cited by 7
- K163481: HALF DOME Posterior Lumbar Interbody System (2017), cited by 6
- K160154: ALTA Anterior Cervical Interbody Spacer (2016), cited by 5
- K181139: OLYMPIC Posterior Spinal Fixation System (2018), cited by 4
- K173324: ALTA Anterior Cervical Interbody Spacer (2018), cited by 4

## Recent decisions
- K252885: OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (Jan 22, 2026)
- K252346: OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (Oct 21, 2025)
- K243259: MASADA Modular Spinal Fixation System (Jan 7, 2025)
- K240160: EGPS Navigated Instruments (Oct 17, 2024)
- K233359: DOMINION Expandable Corpectomy System (Mar 8, 2024)
- K231694: MASADA Modular Spinal Fixation System (Nov 16, 2023)
- K232211: REUNION Sacroiliac Joint Fusion System (Oct 24, 2023)
- K223335: SIRION Lateral Lumbar Interbody System (May 9, 2023)

Source page: https://510kreport.com/company/astura-medical