Cement Obturator
10 catalogue numbers from 1109-11, listed by Zimmer, Inc., United States, under Cement Obturator. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | LZN |
| Device type | Cement Obturator |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K001733 |
| Record published | 2018-09-14 |
| Record revised | 2023-02-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 32 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1109-11 | 11 mm | In distribution |
| 1109-09 | 9 mm | In distribution |
| 8011-20-12 | 12 mm Diameter Flange, 7 mm Diameter Core | In distribution |
| 1109-17 | 17 mm | In distribution |
| 8011-20-20 | 20 mm Diameter Flange, 10 mm Diameter Core | In distribution |
| 8011-10-01 | 12 Millimeter Diameter Flange, 7 Millimeter Diameter Core, 16 Millimeter Diameter Flange, 8 Millimeter Diameter Core | In distribution |
| 1109-13 | 13 mm | In distribution |
| 1109-09 | 9 mm | In distribution |
| 1109-13 | 13 mm | In distribution |
| 8011-20-28 | 28 mm Diameter Flange, 14 mm Diameter Core | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clearcut | Teknimed SAS | 13 |
| Exeter | Howmedica Osteonics Corp | 11 |
| Buck | Smith & Nephew, Inc. | 8 |
| DJO Surgical | Encore Medical, L.P. | 6 |
| Spectron | Smith & Nephew, Inc. | 6 |
| Cemstop | Teknimed SAS | 6 |
| MectaPlug | Teknimed SAS | 6 |
| Biostop | Depuy Orthopaedics, Inc. | 5 |
| Bone Plug | Howmedica Osteonics Corp | 3 |
| ACM BioPrep | Stryker GmbH | 2 |
| Perfecta | Microport Orthopedics Inc. | 2 |
| Cement Restrictor | Tornier Inc. | 2 |
Showing 12 of 17. All products under Cement Obturator
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2009-06-08 | Not classified | Packaging process control | The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility. | 133 | 2009-12-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.