Ace Medical Co.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Ace Medical Co.” (first 1987, latest 2020), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 84 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 | 1 | 154 |
| 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 Ace Medical Co. took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 9 | 9 |
| HRS | Plate, Fixation, Bone | 4 | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
| JEC | Component, Traction, Invasive | 2 | 2 |
| HAE | Rongeur, Manual | 1 | 1 |
| HAX | Tong, Skull For Traction | 1 | 1 |
| HXP | Instrument, Bending Or Contouring | 1 | 1 |
| LXC | Monitor, Pressure, Intracompartmental | 1 | 1 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 1 | 1 |
Review panels
- Orthopedic (20)
- Neurology (2)
Most recent Ace Medical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200387 | Ace Medical Surgical Instruments | HAE | 2020-07-21 | 154 |
| K972183 | DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL | HSB | 1997-08-26 | 77 |
| K955472 | ACE HUMERUS & RADIUS PLATES | HRS | 1996-04-01 | 123 |
| K955388 | ACE-DUPONT COMPOSITE RINGS | LXT | 1996-01-31 | 68 |
| K954485 | 6.5MM SOLID CANCELLOUS BONE SCREW | HWC | 1995-10-31 | 34 |
| K954069 | ACE CERVICAL TRACTION HALOZS, TONGS & PINS | HAX | 1995-10-12 | 43 |
| K950618 | ACE SUPRACONDYLAR PLATE | HRS | 1995-05-10 | 89 |
| K933968 | ACE PELVIC STABILIZER | JEC | 1994-06-16 | 304 |
| K931652 | ACE 6.5 MM BONE SCREW | HWC | 1994-04-28 | 388 |
| K930592 | ACE UNIVERSAL RECONSTRUCTION PLATE | HRS | 1993-07-26 | 172 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ace Medical Co..
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 Ace Medical Co.?
FDA lists 22 510(k) clearances under the applicant name “Ace Medical Co.” (first 1987, latest 2020), across 9 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 Ace Medical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ace Medical Co. is 84 days.
Which FDA product codes appear under Ace Medical Co.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 9); HRS (Plate, Fixation, Bone, 4); HSB (Rod, Fixation, Intramedullary And Accessories, 2).
Next steps
- See all 22 Ace Medical Co. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Ace Medical Co.'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.