Data / Medical devices / United States / ETEX Corporation
ETEX Corporation: FDA-registered device maker in Braintree, MA, United States, 2 510(k) clearances
ETEX Corporation is registered with the FDA (registration 1225112) in Braintree, MA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 10, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1225112
- FEI number
- 3000206397
- Address
- 55 Messina Dr, Braintree, MA, United States, 02184
- Owner or operator
- Zimmer Biomet ETEX (9014709)
- Roles
- Manufacturer for export, Specification developer
- First device listed
- June 29, 2018
- Registered through
- 2027
- Brand names listed
- AccuFill, AccuFill PF, AccuFill; AccuFill PreFill, CarriGen PF
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 2 | Specification developer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions | QCG | N | Manufacturer for export | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 10, 2019 | K190814 | AccuFill Bone Substitute Material | MQV | Substantially Equivalent | Zimmer Knee Creations | accessdata.fda.gov |
| August 31, 2018 | K182107 | CarriGen PF | MQV | Substantially Equivalent | Etex Corporation | accessdata.fda.gov |
Compare with other makers
Updated June 10, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.