Plug
Distal Hole Plug
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | LZN |
| Device type | Cement Obturator |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K992462 |
| Record published | 2015-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1067-0002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clearcut | Teknimed SAS | 13 |
| Exeter | Howmedica Osteonics Corp | 11 |
| Cement Obturator | Zimmer, Inc. | 10 |
| 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 |
Showing 12 of 17. All products under Cement Obturator
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K992462 | 1999-08-13 |
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.