Data / Medical devices / United States / Inosys, Inc.
Inosys, Inc.: FDA-registered device maker in New York, NY, United States, 2 510(k) clearances
Inosys, Inc. is registered with the FDA (registration 3022316560) in New York, NY, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 17, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022316560
- Address
- 545 W 45th St Fl 11, New York, NY, United States, 10036
- Owner or operator
- INOSYS, INC. (10084921)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- April 15, 2022
- Registered through
- 2026
- Brand names listed
- Abutment Screw, Cemented Abutment (HEX), Cemented Abutment (NON-HEX), Closing Screw, Cover Screw, Healing Abutment, INOSS Abutment, INOSS Fixture and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Repackager or relabeler, 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 17, 2026 | K260006 | INOSS System | DZE | Substantially Equivalent | Inosys, Inc. | accessdata.fda.gov |
| January 31, 2018 | K171297 | AR_N Type Implant System | DZE | Substantially Equivalent | Biotem Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 17, 2026. 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.