510(k) K972322 ยท JEY Plate, Bone
LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES
| Applicant | Walter Lorenz Surgical, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Aug 18, 1997 |
| Received | Jun 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972322
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2020 | Biomet, Inc. Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.