Apatech , Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Apatech , Ltd.” (first 2004, latest 2009), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 100 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 |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 7 | 7 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
Review panels
- Orthopedic (7)
- Dental (1)
Most recent Apatech , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090850 | ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE | LYC | 2009-07-30 | 122 |
| K082575 | ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES | MQV | 2008-11-25 | 81 |
| K081979 | ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE | MQV | 2008-11-06 | 118 |
| K082073 | ACTIFUSE FLOW BONE GRAFT SUBSTITUTE | MQV | 2008-09-11 | 50 |
| K080736 | ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE | MQV | 2008-04-16 | 30 |
| K071206 | ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE | MQV | 2007-05-31 | 30 |
| K040082 | PORE-SI BONE GRAFT SUBSTITUTE | MQV | 2004-08-04 | 202 |
| K033722 | APAPORE BONE GRAFT SUBSTITUTE | MQV | 2004-05-07 | 163 |
Recalls
openFDA lists no recalls under a recalling firm named Apatech , Ltd..
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 Apatech , Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Apatech , Ltd.” (first 2004, latest 2009), across 2 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 Apatech , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Apatech , Ltd. is 100 days.
Which FDA product codes appear under Apatech , Ltd.?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 7); LYC (Bone Grafting Material, Synthetic, 1).
Next steps
- See all 8 Apatech , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MQV, Apatech , Ltd.'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.