510(k) K072806 ยท HAW Neurological Stereotaxic Instrument
MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
| Applicant | Mako Surgical Corp., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Jan 24, 2008 |
| Received | Oct 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072806
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2009 | Mako Surgical Corporation Tibial Array and Femoral Array.
Model Number(s): 0150ARR00001 and 0150ARR00002.
Manufactured by: MAKO Surgical, Corp.
The devices are accessories used with MAKO's Tactile Guidance System (TGS). The Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.