Data / Medical devices / Spain / ZimVie Spain S.L.U.
ZimVie Spain S.L.U.: FDA-registered device maker in Paterna Valencia(Province), Spain, 1 510(k) clearance
ZimVie Spain S.L.U. is registered with the FDA (registration 3009840806) in Paterna Valencia(Province), Spain. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 28, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009840806
- Address
- c/Islas Baleares, 50 Pol. Ind. Fuente del Jarro, Paterna Valencia(Province), Spain, 46988
- Owner or operator
- ZimVie US Corp LLC (1038806)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 29, 1993
- Registered through
- 2026
- Brand names listed
- 3i T3 Ex Hex Parallel Walled Implant, 3i T3 Ex Hex Tapered Implant, 3i T3 Non-Platform Switched Parallel Walled Implant, 3i T3 Non-Platform Switched Tapered Implant, 3i T3 Parallel Walled Implant, 3i T3 Short External Hex Parallel Walled Implant, 3i T3 Short External Hex Parallel Walled Implant with DCD, 3i T3 Tapered Implant and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Contract manufacturer | accessdata.fda.gov |
| Attachment, Precision, All | EGG | 1 | Contract manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 28, 2022 | K213672 | T3 Pro Implants | DZE | Substantially Equivalent | Biomet 3i, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Attachment, Precision, All
- All makers of Tray, Surgical, Instrument
Updated March 28, 2022. 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.