SLR-Plus
SLR-Plus Trial Broach 11
9manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | LWJ |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K123598 |
| Record published | 2016-08-19 |
| Record revised | 2023-09-07 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 75017272 | In distribution | |
| 75017279 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Iconacy i-Hip | Iconacy Orthopedic Implants, LLC | 154 |
| ZMR® | Zimmer, Inc. | 129 |
| Instrument | Howmedica Osteonics Corp | 120 |
| Restoration | Howmedica Osteonics Corp | 66 |
| U2 Hip Stem | United Orthopedic Corp. | 60 |
| Trinity Acetabular Hip System | Corin Limited | 58 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Exactech, Inc. | 51 |
| Omnifit | Howmedica Osteonics Corp | 48 |
| Novation | Exactech, Inc. | 48 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 46 |
| Trident | Howmedica Osteonics Corp | 43 |
| Kinectiv® | Zimmer, Inc. | 41 |
Showing 12 of 131. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
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 |
|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2016-11-16 | Class II | Process control | The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound. | 4444 units | 2019-08-19 |
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.