# Aegis Spine, Inc.

- Location (FDA's records): Englewood, CO
- FDA decisions: 6 (2021–2023): 6 510(k) clearances
- Names in FDA's records: Aegis Spine, Inc. (5); Aegis Spine (1)
- Product codes: OUR (3), MAX (2), KWQ (1)
- 510(k) review time since 2016: median 58 days, against 90 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 23 (5 its own); citations of its devices by later devices: 13 (5 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
- L&K BIOMED Co., Ltd.: 8 (https://510kreport.com/company/l-k-biomed)
- Theken Spine, LLC: 2 (https://510kreport.com/company/theken-spine)
- GS Medical Co., Ltd.: 2 (https://510kreport.com/company/gs-medical)
- Corelink, LLC: 1 (https://510kreport.com/company/corelink)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Zimmer Spine, Inc.: 1 (https://510kreport.com/company/zimmer-spine)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Xenco Medical, LLC: 1 (https://510kreport.com/company/xenco-medical)

## Firms that cite its devices most
- L&K BIOMED Co., Ltd.: 7 (https://510kreport.com/company/l-k-biomed)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)

## Its most-cited devices
- K210035: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System (2021), cited by 6
- K221050: ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System (2022), cited by 3
- K223521: ZESPIN SI Joint Fusion System (2023), cited by 1
- K203531: XYPAN Expandable Lumbar Cage System (2021), cited by 1
- K223719: Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System (2023), cited by 1
- K221719: ABTross ALIF Expandable Cage System (2022), cited by 1

## Recent decisions
- K223521: ZESPIN SI Joint Fusion System (Jan 20, 2023)
- K223719: Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System (Jan 11, 2023)
- K221719: ABTross ALIF Expandable Cage System (Nov 3, 2022)
- K221050: ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System (Jun 30, 2022)
- K210035: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System (Feb 16, 2021)
- K203531: XYPAN Expandable Lumbar Cage System (Jan 29, 2021)

Source page: https://510kreport.com/company/aegis-spine