Arrow®
17 catalogue numbers from 265152 - CoCr GLENOSPHERE, Ø42, listed by Fournitures Hospitalieres Industrie, United States, under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Fournitures Hospitalieres Industrie, United States |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| 510(k) | K112193 |
| Record published | 2015-10-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 265152 – CoCr GLENOSPHERE, Ø42 | In distribution | |
| 268017 – extended stopped drill bit Ø5 | In distribution | |
| 265167 – CANCELLOUS BONE SCREW, Ø5,5 L50 | In distribution | |
| 265146 – STD HUMERAL INSERT, Ø39 / H10 | In distribution | |
| 269240 – quick-release peripheral drill Ø5 (x2) | In distribution | |
| 265168 – CORTICAL BONE SCREW, Ø4,5 L32 | In distribution | |
| 265148 – STD HUMERAL INSERT, Ø42 / H05 | In distribution | |
| 265150 – CoCr GLENOSPHERE, Ø36 | In distribution | |
| 265154 – CEMENTLESS METAL-BACK GLENOID BASE, S46 | In distribution | |
| 265170 – CORTICAL BONE SCREW, Ø4,5 L36 | In distribution | |
| 265144 – STD HUMERAL INSERT, Ø39 / H00 | In distribution | |
| 265163 – CANCELLOUS BONE SCREW, Ø5,5 L36 | In distribution | |
| 268016 – extended cutting guide pins (x4) | In distribution | |
| 265172 – CORTICAL BONE SCREW, Ø4,5 L40 | In distribution | |
| 265165 – CANCELLOUS BONE SCREW, Ø5,5 L40 | In distribution | |
| 269138 – threaded pin Ø3 L170 | In distribution | |
| 265142 – STD HUMERAL INSERT, Ø36 / H05 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 336 |
| SMR Shoulder | Limacorporate | 289 |
| Tornier Perform Humeral System | Tornier Inc. | 119 |
| Bigliani/Flatow® | Zimmer, Inc. | 119 |
| Trabecular Metal® | Zimmer, Inc. | 115 |
| Jarvis Glenoid Rerverse Shoulder Prosthesis | Fournitures Hospitalieres Industrie | 103 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 86 |
| Alliance® | Zimmer, Inc. | 68 |
| Anatomical Shoulder™ | Zimmer, Inc. | 54 |
| Aetos Shoulder System | Smith & Nephew, Inc. | 53 |
| Perform™ Humeral System | Tornier Inc. | 47 |
| Bio-Modular® Shoulder System | Biomet Orthopedics | 43 |
Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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.