Cofield
Modified C2 Glen Keel Cutter F/USE W/Angle Driver
8manufacturers in China registered for this device type
39catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K121714 |
| Record published | 2015-08-29 |
| Record revised | 2023-10-04 (version 9) |
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 |
| Distribution end date | 2022-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71249706 | In distribution | |
| 71249801 | Withdrawn | |
| 71249110 | Withdrawn | |
| 71249803 | Withdrawn | |
| 71249108 | Withdrawn | |
| 71249512 | Withdrawn | |
| 71928986 | Withdrawn | |
| 71249852 | Withdrawn | |
| 71249833 | Withdrawn | |
| 71249508 | Withdrawn | |
| 71249832 | Withdrawn | |
| 71928985 | Withdrawn | |
| 71249646 | Withdrawn | |
| 71249835 | Withdrawn | |
| 71249863 | Withdrawn | |
| 71249516 | Withdrawn | |
| 71249836 | Withdrawn | |
| 71249212 | Withdrawn | |
| 71249864 | Withdrawn | |
| 71249853 | Withdrawn | |
| 71249114 | Withdrawn | |
| 71249802 | Withdrawn | |
| 71249510 | Withdrawn | |
| 71249208 | Withdrawn | |
| 71249210 | Withdrawn | |
| 71249712 | Withdrawn | |
| 71928983 | Withdrawn | |
| 71249851 | Withdrawn | |
| 71249116 | Withdrawn | |
| 71249837 | Withdrawn | |
| 71249831 | Withdrawn | |
| 71249822 | Withdrawn | |
| 71249920 | Withdrawn | |
| 71249506 | Withdrawn | |
| 71249514 | Withdrawn | |
| 71249821 | Withdrawn | |
| 71249823 | Withdrawn | |
| 71928984 | Withdrawn | |
| 71249112 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| Acumed | Acumed LLC | 112 |
| Promos | Smith & Nephew, Inc. | 104 |
| Trabecular Metal® | Zimmer, Inc. | 90 |
| Bigliani/Flatow® | Zimmer, Inc. | 86 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 85 |
| Arthrex® | Arthrex, Inc. | 75 |
| SMR System | Limacorporate | 72 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121714 | 2012-09-07 |
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.