Immedica, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Immedica, Inc.” (first 1999, latest 2003), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 76 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 |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 5 | 5 |
| GXP | Methyl Methacrylate For Cranioplasty | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| LOD | Bone Cement | 1 | 1 |
Review panels
- Orthopedic (7)
- Neurology (1)
Most recent Immedica, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023575 | CONCERT CRANIOPLAST | GXP | 2003-01-22 | 90 |
| K013755 | CONCERT RADIOPAQUE BONE CEMENT | LOD | 2002-02-08 | 87 |
| K003205 | TRANSFX ANGLED RODS | LXT | 2000-12-15 | 63 |
| K001228 | EXTERNAL FIXATION ANCHOR PIN | JDW | 2000-07-07 | 81 |
| K001084 | TRANS FX ADJUSTABLE PIN TO BAR CLAMP | LXT | 2000-06-15 | 72 |
| K991723 | TRANSFX MULTI PIN CLAMP | LXT | 1999-07-22 | 63 |
| K990848 | TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION | LXT | 1999-05-17 | 63 |
| K984357 | TRANSFX EXTERNAL FIXATION SYSTEM | LXT | 1999-03-04 | 87 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-02-10.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Immedica, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Immedica, Inc.” (first 1999, latest 2003), across 4 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 Immedica, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Immedica, Inc. is 76 days.
Which FDA product codes appear under Immedica, Inc.?
The most frequent FDA product codes under this applicant name are LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite, 5); GXP (Methyl Methacrylate For Cranioplasty, 1); JDW (Pin, Fixation, Threaded, 1).
Next steps
- See all 8 Immedica, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LXT, Immedica, 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.