Data / Medical devices / United States / Osypka Medtec Inc.
Osypka Medtec Inc.: FDA-registered device maker in Longmont, CO, United States, 2 510(k) clearances
Osypka Medtec Inc. is registered with the FDA (registration 3010376846) in Longmont, CO, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 16, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010376846
- Address
- 1804 Skyway Dr Unit E, Longmont, CO, United States, 80504
- Owner or operator
- Osypka Medtec Inc. (10044669)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- July 11, 2013
- Registered through
- 2026
- Brand names listed
- Otomag Alpha (M) Magnetic Implant, Stimulator Hypoglossal Nerve Implanted Apnea
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hearing Aid, Bone Conduction | LXB | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Hypoglossal Nerve, Implanted, Apnea | MNQ | 3 | Contract 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 |
|---|---|---|---|---|---|---|
| June 16, 2016 | K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | LXB | Substantially Equivalent | Sophono, Inc. | accessdata.fda.gov |
| May 23, 2011 | K102199 | OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) | LXB | Substantially Equivalent | Sophono, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Hearing Aid, Bone Conduction
- All makers of Stimulator, Hypoglossal Nerve, Implanted, Apnea
Updated June 16, 2016. 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.