Aegis Spine, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Aegis Spine, Inc.” (first 2021, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 58 days. Since 2017 the median was 58 days, against 92 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 2 | 50 |
| 2022 | 2 | 112 |
| 2023 | 2 | 44 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Aegis Spine, Inc. took a median 58 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Aegis Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223521 | ZESPIN SI Joint Fusion System | OUR | 2023-01-20 | 58 |
| K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | KWQ | 2023-01-11 | 30 |
| K221719 | ABTross ALIF Expandable Cage System | MAX | 2022-11-03 | 143 |
| K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System | OUR | 2022-06-30 | 80 |
| K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System | OUR | 2021-02-16 | 41 |
| K203531 | XYPAN Expandable Lumbar Cage System | MAX | 2021-01-29 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Aegis Spine, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Aegis Surgical, Ltd. (2 510(k)s)
- Aegis Medical Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aegis Spine, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Aegis Spine, Inc.” (first 2021, latest 2023), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aegis Spine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aegis Spine, Inc. is 58 days. Since 2017: 58 days, versus 92 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Aegis Spine, Inc.?
The most frequent FDA product codes under this applicant name are OUR (Sacroiliac Joint Fixation, 3); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1).
Next steps
- See all 6 Aegis Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OUR, Aegis Spine, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.