Data / Medical devices / United States / Agnovos Healthcare Usa, LLC
Agnovos Healthcare Usa, LLC: FDA-registered device maker in Rockville, MD, United States, 2 510(k) clearances
Agnovos Healthcare Usa, LLC is registered with the FDA (registration 3011662387) in Rockville, MD, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 20, 2018. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3011662387
- Address
- 7301 Calhoun PL Ste 100, Rockville, MD, United States, 20855
- Owner or operator
- AgNovos Healthcare (10055038)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 4, 2018
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 2 | Complaint file establishment, 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 20, 2018 | K181585 | JGH1 Core Deccompression Procedure Kit | MQV | Substantially Equivalent | AgNovos Healthcare USA, LLC | accessdata.fda.gov |
| July 19, 2018 | K181342 | JGH1 Bone Graft Substitute | MQV | Substantially Equivalent | AgNovos Healthcare USA, LLC | accessdata.fda.gov |
Compare with other makers
Updated July 20, 2018. 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.