Emerge Medical: FDA clearances and approvals
Emerge Medical has 11 FDA 510(k) clearances (first 2010, latest 2014), across 4 product codes in 1 review panel. Median 510(k) review time: 71 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 117 |
| 2013 | 1 | 42 |
| 2014 | 8 | 64 |
| 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 | 7 | 7 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent Emerge Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141347 | EMERGE MEDICAL IM NAIL SYSTEM | HSB | 2014-10-02 | 133 |
| K140675 | EMERGE EXTERNAL FIXATION SYSTEM | KTT | 2014-06-10 | 84 |
| K140107 | EMERGE MEDICAL DISTAL RADIUS SET | HRS | 2014-03-13 | 57 |
| K140119 | EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM | HRS | 2014-03-12 | 55 |
| K140098 | EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM | HRS | 2014-03-12 | 57 |
| K133536 | EMERGE MEDICAL BONE PLATE SYSTEM | HRS | 2014-02-26 | 100 |
| K133541 | EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM | HRS | 2014-01-28 | 71 |
| K133452 | EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM | HRS | 2014-01-08 | 57 |
| K131480 | EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM | HRS | 2013-07-03 | 42 |
| K122489 | EMERGE MEDICAL SOLID BONE SCREWS | HWC | 2012-12-10 | 117 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Emerge Medical.
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 Emerge Medical have?
Emerge Medical has 11 FDA 510(k) clearances (first 2010, latest 2014), across 4 product codes in 1 review panel.
How long does FDA take to clear Emerge Medical's 510(k)s?
The median time from FDA receipt to decision across Emerge Medical's cleared 510(k)s is 71 days.
What devices does Emerge Medical make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 7); HWC (Screw, Fixation, Bone, 2); HSB (Rod, Fixation, Intramedullary And Accessories, 1).
Has Emerge Medical had device recalls?
openFDA lists no recalls under a recalling firm name matching Emerge Medical. Related entities may recall under other names.
Next steps
- See all 11 Emerge Medical clearances with predicates and recalls
- Run predicate analysis for product code HRS, Emerge Medical'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.