Company ยท US
Aegis Spine, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2023. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 20, 2023 | K223521 | ZESPIN SI Joint Fusion System Aegis Spine, Inc. | OUR |
| Jan 11, 2023 | K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System Aegis Spine, Inc. | KWQ |
| Nov 3, 2022 | K221719 | ABTross ALIF Expandable Cage System Aegis Spine, Inc. | MAX |
| Jun 30, 2022 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema L Aegis Spine, Inc. | OUR |
| Feb 16, 2021 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Aegis Spine | OUR |
| Jan 29, 2021 | K203531 | XYPAN Expandable Lumbar Cage System Aegis Spine, Inc. | MAX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||