Depuyacromed: FDA clearances and approvals
Depuyacromed has 48 FDA 510(k) clearances (first 1999, latest 2004), across 11 product codes in 4 review panels. Median 510(k) review time: 30 days.
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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 13 | 13 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 10 | 10 |
| MQP | Spinal Vertebral Body Replacement Device | 8 | 8 |
| MNI | Orthosis, Spinal Pedicle Fixation | 6 | 6 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 | 4 |
| LYC | Bone Grafting Material, Synthetic | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 1 | 1 |
| JEC | Component, Traction, Invasive | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (44)
- Dental (2)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Depuyacromed 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040197 | EAGLE ANTERIOR CERVIAL PLATE SYSTEM | KWQ | 2004-04-02 | 64 |
| K031635 | DEPUY ACROMED VBR SYSTEM | MQP | 2003-06-23 | 27 |
| K030833 | DEPUY ACROMED VBR SYSTEM | MQP | 2003-04-10 | 24 |
| K030383 | MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS | MNH | 2003-02-26 | 21 |
| K030249 | SURGICAL TITANIUM MESH SYSTEM | MQP | 2003-02-14 | 21 |
| K030103 | SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS | MNI | 2003-02-05 | 23 |
| K023835 | DEVEX MESH SYSTEM | MQP | 2003-01-29 | 72 |
| K024348 | MONARCH SPINE SYSTEM | MNH | 2003-01-28 | 29 |
| K023804 | MOSS MIAMI SPINAL SYSTEM PIN NUT | KWP | 2003-01-23 | 70 |
| K021039 | BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM | KWQ | 2002-12-11 | 254 |
38 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Depuyacromed.
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 Depuyacromed have?
Depuyacromed has 48 FDA 510(k) clearances (first 1999, latest 2004), across 11 product codes in 4 review panels.
How long does FDA take to clear Depuyacromed's 510(k)s?
The median time from FDA receipt to decision across Depuyacromed's cleared 510(k)s is 30 days.
What devices does Depuyacromed make?
Its most frequent FDA product codes are MNH (Orthosis, Spondylolisthesis Spinal Fixation, 13); KWP (Appliance, Fixation, Spinal Interlaminal, 10); MQP (Spinal Vertebral Body Replacement Device, 8).
Has Depuyacromed had device recalls?
openFDA lists no recalls under a recalling firm name matching Depuyacromed. Related entities may recall under other names.
Next steps
- See all 48 Depuyacromed clearances with predicates and recalls
- Run predicate analysis for product code MNH, Depuyacromed'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.