Ace Orthopedic Manufacturing Co.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Ace Orthopedic Manufacturing Co.” (first 1977, latest 1994), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| JEC | Component, Traction, Invasive | 5 | 5 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
| HAX | Tong, Skull For Traction | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| HXK | Holder, Needle; Orthopedic | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
Review panels
- Orthopedic (12)
- Gastroenterology and Urology (1)
- Neurology (1)
Most recent Ace Orthopedic Manufacturing Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934962 | AIM SUPRACONDYLAR NAIL | HSB | 1994-03-22 | 155 |
| K934643 | ACE HUMERAL NAIL | HSB | 1994-03-22 | 174 |
| K936045 | ACE UNILATERAL FIXATOR II | JEC | 1994-02-22 | 64 |
| K926047 | ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW | HWC | 1993-03-31 | 120 |
| K920738 | ACE 100 DEGREES TUBULAR PLATE | HRS | 1992-07-27 | 159 |
| K813554 | ACE/KYLE CAPTURED HIP SCREW | KTT | 1982-01-12 | 21 |
| K810193 | TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG | HAX | 1981-03-20 | 56 |
| K801594 | ACE FISCHER EXTERNAL FIXATION DEVICE | HXK | 1980-09-09 | 57 |
| K791466 | ACE EXTERNAL BONE CLAMP PART #S11 | JEC | 1979-08-16 | 15 |
| K781841 | BAR, DISTRACTION | JEC | 1978-11-08 | 12 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ace Orthopedic Manufacturing 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 Orthopedic Manufacturing Co.?
FDA lists 14 510(k) clearances under the applicant name “Ace Orthopedic Manufacturing Co.” (first 1977, latest 1994), across 9 product codes in 3 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 Orthopedic Manufacturing Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ace Orthopedic Manufacturing Co. is 56 days.
Which FDA product codes appear under Ace Orthopedic Manufacturing Co.?
The most frequent FDA product codes under this applicant name are JEC (Component, Traction, Invasive, 5); HSB (Rod, Fixation, Intramedullary And Accessories, 2); HAX (Tong, Skull For Traction, 1).
Next steps
- See all 14 Ace Orthopedic Manufacturing Co. clearances with predicates and recalls
- Run predicate analysis for product code JEC, Ace Orthopedic Manufacturing 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.