510(k) K032945 ยท LOD Bone Cement
SIMPLEX X
| Applicant | Stryker Corp., Kalamazoo MI, US |
| Decision | Substantially Equivalent, May 25, 2004 |
| Received | Sep 22, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032945
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259
Bone cement. Terminated |
LOD | None listed |
| Jan 25, 2012 | Stryker Instruments Div. of Stryker Corporation Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Stryker Instruments, Kalamazoo, MI
Part Number: 0505-585-000, Lot:11223012
Terminated |
JDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.