Aegis Spine, Inc.
Englewood, CO, US
Aegis Spine, Inc. appears in FDA device records in Englewood, CO. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 6
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 6 510(k) clearances for Aegis Spine, Inc. between 2021 and 2023. The busiest year on record is 2021, with 2. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223521 | ZESPIN SI Joint Fusion System | OUR | Substantially Equivalent | |
| K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | KWQ | Substantially Equivalent | |
| K221719 | ABTross ALIF Expandable Cage System | MAX | Substantially Equivalent | |
| K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System | OUR | Substantially Equivalent | |
| K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System | OUR | Substantially Equivalent | |
| K203531 | XYPAN Expandable Lumbar Cage System | MAX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain