Etex Corp.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under 3 spellings of the applicant name “Etex Corp.” (first 1992, latest 2024), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 89 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 | 1 | 56 |
| 2015 | 1 | 525 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 28 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 26 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Etex Corp. took a median 27 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 175 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 14 | 14 |
| LYC | Bone Grafting Material, Synthetic | 4 | 4 |
| GXP | Methyl Methacrylate For Cranioplasty | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 1 | 1 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 1 | 1 |
Review panels
- Orthopedic (17)
- Dental (5)
- Neurology (2)
- General Hospital (1)
Most recent Etex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243609 | EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) | MQV | 2024-12-18 | 26 |
| K182107 | CarriGen PF | MQV | 2018-08-31 | 28 |
| K132868 | CARRICELL | MQV | 2015-02-20 | 525 |
| K141245 | ETEX MIXING AND DELIVERY SYSTEM | FMF | 2014-07-09 | 56 |
| K100883 | CARRIGEN | LYC | 2010-12-21 | 266 |
| K102812 | GAMMA-BSM; BETA-BSM; EQUIVABONE | LYC | 2010-12-03 | 66 |
| K101557 | GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN | MQV | 2010-07-01 | 27 |
| K093447 | CARRIGEN | MQV | 2010-02-18 | 105 |
| K091729 | ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE | LYC | 2009-12-23 | 195 |
| K091607 | ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE | MQV | 2009-11-02 | 152 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Etex Corp..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Etex Corp. (a text match, not an official crosswalk):
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Etex Corp. (18)
- Etex Corporation (5)
- Etex Co. (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Etex Corp.?
FDA lists 25 510(k) clearances under 3 spellings of the applicant name “Etex Corp.” (first 1992, latest 2024), across 8 product codes in 4 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 Etex Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Etex Corp. is 89 days.
Which FDA product codes appear under Etex Corp.?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 14); LYC (Bone Grafting Material, Synthetic, 4); GXP (Methyl Methacrylate For Cranioplasty, 2).
Next steps
- See all 25 Etex Corp. clearances with predicates and recalls
- Run predicate analysis for product code MQV, Etex Corp.'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.