510(k) K912190 ยท JDZ Mixer, Cement, For Clinical Use
STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
| Applicant | Stryker Corp., Kalamazoo MI, US |
| Decision | Substantially Equivalent, Aug 29, 1991 |
| Received | May 17, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912190
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Jul 29, 2003 | Stryker Instruments, Instruments Div. Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000. Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.