Buck
18.5MM Buck Cement Plug With Disposable Inserter
3manufacturers in China registered for this device type
8catalogue numbers in this listing
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 | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | LZN |
| Device type | Cement Obturator |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K211176 |
| Record published | 2015-08-30 |
| Record revised | 2025-07-23 (version 8) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 914535 | In distribution | |
| 71279421 | In distribution | |
| 71279424 | In distribution | |
| 129419 | In distribution | |
| 71279423 | In distribution | |
| 71279420 | In distribution | |
| 129418 | In distribution | |
| 71279422 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clearcut | Teknimed SAS | 13 |
| Exeter | Howmedica Osteonics Corp | 11 |
| Cement Obturator | Zimmer, Inc. | 10 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K023680 | 2002-11-19 |
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.