510(k) K931847 ยท LZN Cement Obturator
BIO-PREP CEMENT RESTRICTOR
| Applicant | Biomedical Devices, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 28, 1994 |
| Received | Apr 13, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931847
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2023 | Stryker Corporation Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process.
Catalog number: 0206-512-000. Open, Classified |
LZN | None listed |
| Sep 19, 2023 | Stryker Corporation Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with
a constant high vacuum through the process
Catalog Number: 0206-53 Open, Classified |
LZN | None listed |
| Sep 19, 2023 | Stryker Corporation Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process
Catalog Number: 0306-563-000 Open, Classified |
LZN | None listed |
| Sep 19, 2023 | Stryker Corporation Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process
Catalog Number: 0306- Open, Classified |
LZN | None listed |
| Sep 19, 2023 | Stryker Corporation Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process
Catalog Number: 0 Open, Classified |
LZN | None listed |
| Sep 19, 2023 | Stryker Corporation Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process
Catalog Nu Open, Classified |
LZN | None listed |
| Sep 19, 2023 | Stryker Corporation Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement with a constant high vacuum through the process.
Cat Open, Classified |
LZN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.