Expanding Innovations, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Expanding Innovations, Inc.” (first 2020, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 83 days. Since 2017 the median was 83 days, against 93 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 |
|---|---|---|
| 2020 | 1 | 134 |
| 2021 | 1 | 161 |
| 2022 | 2 | 22 |
| 2023 | 1 | 126 |
| 2024 | 0 | — |
| 2025 | 3 | 81 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Expanding Innovations, Inc. took a median 83 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 7 | 7 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Expanding Innovations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251003 | X-PAC® LLIF Expandable Lateral Cage System | MAX | 2025-06-25 | 85 |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | MAX | 2025-06-16 | 20 |
| K250602 | X-PAC® N-GAGE Lumbar Plate System | KWQ | 2025-05-20 | 81 |
| K223174 | X-Pac Expandable LLIF Cage System | MAX | 2023-02-14 | 126 |
| K222797 | X-Pac Expandable Lumbar Cage System | MAX | 2022-10-14 | 28 |
| K220655 | X-Pac Expandable Lumbar Cage System | MAX | 2022-03-24 | 17 |
| K203802 | X-Pac Expandable Lumbar Cage System | MAX | 2021-06-07 | 161 |
| K201145 | X-Pac Expandable Lumbar Cage System | MAX | 2020-09-10 | 134 |
Recalls
openFDA lists no recalls under a recalling firm named Expanding Innovations, 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.
- Expanding Orthopedics, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Expanding Innovations, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Expanding Innovations, Inc.” (first 2020, latest 2025), across 2 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 Expanding Innovations, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Expanding Innovations, Inc. is 83 days. Since 2017: 83 days, versus 93 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Expanding Innovations, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 7); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1).
Next steps
- See all 8 Expanding Innovations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Expanding Innovations, 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.