510(k) K943727 ยท LZN Cement Obturator
BIOSTOP G BONE CEMENT RESTRICTOR
| Applicant | Landos, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, May 11, 1995 |
| Received | Aug 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943727
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2023 | Depuy Ireland UC BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR
Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size Open, Classified |
LZN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.