510(k) K181544 ยท GZL Electrode, Depth
Anchor Bolt (as an accessory to Depth Electrodes)
| Applicant | Ad-Tech Medical Instrument Corporation, Oak Creek WI, US |
| Decision | Substantially Equivalent, Aug 9, 2018 |
| Received | Jun 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181544
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2019 | Ad-Tech Medical Instrument Corporation Skull Anchor Bolts Terminated |
GZL | None listed |
| Jun 18, 2019 | Ad-Tech Medical Instrument Corporation LSB Style Anchor Bolt. Labeled with the following parts:
13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor b Terminated |
GZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.