510(k) K170442 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cranial Drill Bits and Accessories
| Applicant | Ad-Tech Medical Instrument Corporation, Racine WI, US |
| Decision | Substantially Equivalent, Sep 7, 2017 |
| Received | Feb 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2019 | Ad-Tech Medical Instrument Corporation AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits:
(a) REF DSG-90-2.3N
(b) REF DSG-6.3-090-2.4N Terminated |
HBG | None listed |
| May 2, 2018 | Ad-Tech Medical Instrument Corporation AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628.
Product Usage:
The d Terminated |
HBE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.