Augmenix, Inc.: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Augmenix, Inc.” (first 2013, latest 2019), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 116 days. 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 |
|---|---|---|
| 2013 | 1 | 202 |
| 2014 | 0 | — |
| 2015 | 1 | 30 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 21 |
| 2019 | 1 | 266 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Augmenix, Inc. took a median 144 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OVB | Hydrogel Spacer | 3 | 2 |
| NEU | Marker, Radiographic, Implantable | 2 | 2 |
Review panels
Most recent Augmenix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182971 | SpaceOAR Vue Hydrogel | OVB | 2019-07-19 | 266 |
| K181465 | SpaceOAR System | OVB | 2018-06-25 | 21 |
| K151998 | TraceIT Tissue Marker - 3mL | NEU | 2015-08-19 | 30 |
| K121964 | MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML | NEU | 2013-01-23 | 202 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140030 | De Novo | Hydrogel Spacer | 2015-04-01 |
Recalls
openFDA lists no recalls under a recalling firm named Augmenix, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Augmenix, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Augmenix, Inc.?
FDA lists 4 510(k) clearances under the applicant name “Augmenix, Inc.” (first 2013, latest 2019), plus 1 De Novo decision, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Augmenix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Augmenix, Inc. is 116 days.
Which FDA product codes appear under Augmenix, Inc.?
The most frequent FDA product codes under this applicant name are OVB (Hydrogel Spacer, 3); NEU (Marker, Radiographic, Implantable, 2).
Next steps
- See all 4 Augmenix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OVB, Augmenix, 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.