510(k) K012380 ยท HAW Neurological Stereotaxic Instrument
MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
| Applicant | Stryker Leibinger, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Dec 3, 2001 |
| Received | Jul 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012380
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2017 | Stryker Instruments Div. of Stryker Corporation The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of
the navigation software and creation of a pathway into the pedicle. The instrument has three
types of butto Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.