Data / Medical devices / United States / Medynus, Inc.
Medynus, Inc.: FDA-registered device maker in Irvine, CA, United States, 3 510(k) clearances
Medynus, Inc. is registered with the FDA (registration 3015426608) in Irvine, CA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 3, 2022. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015426608
- Address
- 18 Technology Dr. Suite 109, Irvine, CA, United States, 92618
- Owner or operator
- Medynus, Inc. (10060045)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 16, 2021
- Registered through
- 2026
- Brand names listed
- AWL (OIN-00001), Anti-Torque Device (OIN-00031), BESS Tray with Lid (END-TR001), Ball Tip Tester Double End (OIN-00065), Ball Tip Tester, CR (OIN-00007), Ball Tip Tester, ST (OIN-00006), Bone Curette(3mm) (END-CU05M), Bone Curette(5mm) (END-CU03M) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| March 3, 2022 | K220379 | IMPEACE and IMPEACE-Uni Anterior Cervical Plate System | KWQ | Substantially Equivalent | Medynus, Inc. | accessdata.fda.gov |
| September 23, 2021 | K212792 | Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage | ODP | Substantially Equivalent | Medynus, Inc. | accessdata.fda.gov |
| April 19, 2021 | K210420 | Goblin and Goblin LS Pedicle Screw Systems | NKB | Substantially Equivalent | Medynus, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
Updated March 3, 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.