510(k) K902818 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)
MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT
| Applicant | Ruggles Corp., No. Quincy MA, US |
| Decision | Substantially Equivalent, Sep 20, 1990 |
| Received | Jun 27, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902818
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2013 | Integra Limited Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware.
The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining re Terminated |
HBG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.