Biomatlante: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Biomatlante” (first 2003, latest 2010), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 154 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 | 5 | 5 |
| LYC | Bone Grafting Material, Synthetic | 3 | 3 |
Review panels
- Orthopedic (5)
- Dental (3)
Most recent Biomatlante 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093122 | MBCP+ | LYC | 2010-03-15 | 164 |
| K071121 | TRIBONE 80 | MQV | 2007-09-11 | 144 |
| K063527 | MBCP+ | MQV | 2007-07-30 | 250 |
| K060732 | MBCP GEL | LYC | 2006-06-02 | 74 |
| K051774 | MBCP | MQV | 2006-01-20 | 203 |
| K051885 | MBCP | LYC | 2005-09-16 | 66 |
| K043005 | MODIFICATION TO MBCP | MQV | 2005-05-03 | 183 |
| K032268 | MBCP | MQV | 2003-12-11 | 141 |
Recalls
openFDA lists no recalls under a recalling firm named Biomatlante.
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.
Device clinical trials
An industry sponsor named Biomatlante is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04122677: Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions (Completed, started 2019-11-14)
- NCT04076956: Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions (Completed, started 2019-08-23)
- NCT03978962: Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" (Completed, started 2019-05-28)
- NCT00206791: Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects (Completed, started 2006-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biomatlante?
FDA lists 8 510(k) clearances under the applicant name “Biomatlante” (first 2003, latest 2010), 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 Biomatlante?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomatlante is 154 days.
Which FDA product codes appear under Biomatlante?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 5); LYC (Bone Grafting Material, Synthetic, 3).
Next steps
- See all 8 Biomatlante clearances with predicates and recalls
- Run predicate analysis for product code MQV, Biomatlante'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.