Data / Medical devices / Italy / Gruppo Bioimpianti S.R.L.
Gruppo Bioimpianti S.R.L.: FDA-registered device maker in Peschiera Borromeo Milano, Italy, 2 510(k) clearances
Gruppo Bioimpianti S.R.L. is registered with the FDA (registration 3007391088) in Peschiera Borromeo Milano, Italy. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 22, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007391088
- Address
- Via Liguria 28, Peschiera Borromeo Milano, Italy, 20068
- Owner or operator
- Gruppo Bioimpianti S.r.l. (10051817)
- Roles
- Manufacturer
- First device listed
- May 6, 2016
- Registered through
- 2026
- Brand names listed
- Revival Modular Hip Stem, Revival Modular Revision Hip Stem
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | 2 | 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 |
|---|---|---|---|---|---|---|
| July 22, 2019 | K191374 | Revival Modular Hip Stem | LZO | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| April 29, 2016 | K152903 | REVIVAL(TM) Modular Revision Hip Stem | LZO | Substantially Equivalent | Corin USA | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Updated July 22, 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.