Data / Medical devices / United States / OMNIlife science, Inc.
OMNIlife science, Inc.: FDA-registered device maker in Milpitas, CA, United States, 5 510(k) clearances
OMNIlife science, Inc. is registered with the FDA (registration 3013682146) in Milpitas, CA, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 7, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013682146
- Address
- 880 N McCarthy Blvd Suite 220, Milpitas, CA, United States, 95035
- Owner or operator
- Corin Group (9012268)
- Roles
- Specification developer
- First device listed
- March 4, 2024
- Registered through
- 2026
- Brand names listed
- 4137-2050, 4137-5050, 4144-8000, 4145-1030, 4145-5003, 4145-5004, 4148-1001, 4148-1002 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | 2 | Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| January 7, 2025 | K241808 | ApolloHipX (THR.SS.0001) | LLZ | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| July 26, 2023 | K231172 | ApolloKnee | OLO | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| June 27, 2020 | K200888 | OMNIBotics Knee System | OLO | Substantially Equivalent | Corin, Ltd. | accessdata.fda.gov |
| September 1, 2017 | K163338 | OMNIBotics Knee System | OLO | Substantially Equivalent | Omnllife Science, Inc. | accessdata.fda.gov |
| January 21, 2010 | K090953 | TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK | OLO | Substantially Equivalent | Praxim Medivision, SA | accessdata.fda.gov |
Compare with other makers
Updated January 7, 2025. 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.