Panels › General, Plastic Surgery › Product code LZN · Class 2
Cement Obturator
Regulation 878.3300
0510(k)s in 12 months (37 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in LZN
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Corporation | 0 | 7 |
| Howmedica Corp. | 5 | 0 |
| Allo Pro Corp. | 2 | 0 |
| American Design Group, Inc. | 2 | 0 |
| Isotis NV | 2 | 0 |
| Johnson & Johnson Professionals, Inc. | 2 | 0 |
| Sunmed, Inc. | 2 | 0 |
| Biodynamic Technologies, Inc. | 1 | 0 |
| Biomedical Devices, Inc. | 1 | 0 |
| Biotron , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K931847 |
| 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 | K931847 |
| 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 | K931847 |
| 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 | K931847 |
| 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 | K931847 |
| 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 | K931847 |
| 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 | K931847 |
| 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 | K943727 |
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