Data / Medical devices / United States / COMPASS International Innovations, Inc.
COMPASS International Innovations, Inc.: FDA-registered device maker in Rochester, MN, United States, 4 510(k) clearances
COMPASS International Innovations, Inc. is registered with the FDA (registration 2183671) in Rochester, MN, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 19, 1997. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2183671
- Address
- 1815 14TH ST. NW Suite A, Rochester, MN, United States, 55901
- Owner or operator
- COMPASS INTERNATIONAL (1318929)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 4, 2007
- Registered through
- 2026
- Brand names listed
- COMPASS CT Stereotactic Adaptation, COMPASS Stereotactic Positioning Sy, COMPASS Stereotactic Retractor Sys, Regulus Navigator/CYGNUS-PFS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Retractor, Self-Retaining, For Neurosurgery | GZT | 2 | 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 |
|---|---|---|---|---|---|---|
| August 19, 1997 | K964229 | REGULUS NAVIGATOR | HAW | Substantially Equivalent | Compass Intl., Inc. | accessdata.fda.gov |
| December 6, 1989 | K896156 | COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM | GZT | Substantially Equivalent | Stereotactic Medical Systems, Inc. | accessdata.fda.gov |
| May 8, 1987 | K871046 | COMPASS STEREOTACTIC POSITIONING SYSTEM | HAW | Substantially Equivalent | Stereotactic Medical Systems, Inc. | accessdata.fda.gov |
| June 18, 1986 | K862220 | COMPASS CT STEREOTACTIC ADAPTATION SYSTEM | HAW | Substantially Equivalent | Stereotactic Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Neurological Stereotaxic Instrument
- All makers of Retractor, Self-Retaining, For Neurosurgery
Updated August 19, 1997. 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.