Acute Innovations, LLC: FDA clearances and approvals
Acute Innovations, LLC has 5 FDA 510(k) clearances (first 2006, latest 2012), across 3 product codes in 1 review panel. Median 510(k) review time: 63 days. openFDA lists 2 product recalls by a recalling firm named Acute Innovations, LLC.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 46 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 3 | 3 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Acute Innovations, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120163 | ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM | HRS | 2012-02-17 | 29 |
| K113318 | ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM | HRS | 2012-01-12 | 63 |
| K101170 | ACUTE INNOVATIONS STERNAL FIXATION SYSTEM | KTT | 2010-09-17 | 144 |
| K081588 | RE-ZORB PLATING SYSTEM | HRS | 2008-09-03 | 90 |
| K061206 | ACUTE BONE SCREW | HWC | 2006-06-19 | 49 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2013-10-30.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Acute Innovations, LLC have?
Acute Innovations, LLC has 5 FDA 510(k) clearances (first 2006, latest 2012), across 3 product codes in 1 review panel.
How long does FDA take to clear Acute Innovations, LLC's 510(k)s?
The median time from FDA receipt to decision across Acute Innovations, LLC's cleared 510(k)s is 63 days.
What devices does Acute Innovations, LLC make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 3); HWC (Screw, Fixation, Bone, 1); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 1).
Has Acute Innovations, LLC had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Acute Innovations, LLC; the most recent began 2013-10-30. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Acute Innovations, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRS, Acute Innovations, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.