510(k) K062842 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
TWIST DRILL
| Applicant | Walter Lorenz Surgical, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Dec 4, 2006 |
| Received | Sep 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062842
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2009 | Biomet Microfixation, Inc. Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141.
DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA.
A single use Terminated |
HBE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.