510(k) K152872 ยท KNW Instrument, Biopsy
K2M Fenestrated Tap System
| Applicant | K2m, Leesburg VA, US |
| Decision | Substantially Equivalent, Jan 5, 2016 |
| Received | Sep 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152872
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2019 | K2M, Inc Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015)
Product Usage:
The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone Terminated |
KNW | None listed |
| Apr 18, 2019 | K2M, Inc Fenestrated Tap Adapter (REF# 5001-90011)
Product Usage:
The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for dia Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.