Arrow®
33 catalogue numbers from 265112 - CoCr CENTRED HUMERAL HEAD, Ø46 , listed by Fournitures Hospitalieres Industrie, United States, under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
33catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| 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 | Fournitures Hospitalieres Industrie, United States |
|---|---|
| FDA product code | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K093599 |
| 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 |
|---|---|---|
| 265112 – CoCr CENTRED HUMERAL HEAD, Ø46 H18 | In distribution | |
| 265141 – STD HUMERAL INSERT, Ø36 / H00 | In distribution | |
| 265169 – CORTICAL BONE SCREW, Ø4,5 L34 | In distribution | |
| 265130 – CoCr OFF-CENTRED HUMERAL HEAD, Ø48 H18 | In distribution | |
| 265132 – CoCr OFF-CENTRED HUMERAL HEAD, Ø50 H17 | In distribution | |
| 265116 – CoCr CENTRED HUMERAL HEAD, Ø48 H21 | In distribution | |
| 265105 – HUMERAL STEM, Ø12 L130 | In distribution | |
| 265128 – CoCr OFF-CENTRED HUMERAL HEAD, Ø46 H21 | In distribution | |
| 265164 – CANCELLOUS BONE SCREW, Ø5,5 L38 | In distribution | |
| 265153 – CEMENTLESS METAL-BACK GLENOID BASE, S44 | In distribution | |
| 265171 – CORTICAL BONE SCREW, Ø4,5 L38 | In distribution | |
| 265122 – CoCr CENTRED HUMERAL HEAD, Ø54 H19 | In distribution | |
| 265108 – CoCr CENTRED HUMERAL HEAD, Ø40 H17 | In distribution | |
| 265161 – CANCELLOUS BONE SCREW, Ø5,5 L32 | In distribution | |
| 265136 – CoCr OFF-CENTRED HUMERAL HEAD, Ø52 H21 | In distribution | |
| 265134 – CoCr OFF-CENTRED HUMERAL HEAD, Ø50 H21 | In distribution | |
| 265145 – STD HUMERAL INSERT, Ø39 / H05 | In distribution | |
| 265114 – CoCr CENTRED HUMERAL HEAD, Ø48 H16 | In distribution | |
| 265151 – CoCr GLENOSPHERE, Ø39 | In distribution | |
| 265118 – CoCr CENTRED HUMERAL HEAD, Ø50 H19 | In distribution | |
| 265139 – CEMENTED GLENOID, S48 | In distribution | |
| 265120 – CoCr CENTRED HUMERAL HEAD, Ø52 H19 | In distribution | |
| 265126 – CoCr OFF-CENTRED HUMERAL HEAD, Ø46 H16 | In distribution | |
| 265147 – STD HUMERAL INSERT, Ø42 / H00 | In distribution | |
| 265166 – CANCELLOUS BONE SCREW, Ø5,5 L45 | In distribution | |
| 265124 – CoCr OFF-CENTRED HUMERAL HEAD, Ø44 H16 | In distribution | |
| 265110 – CoCr CENTRED HUMERAL HEAD, Ø44 H18 | In distribution | |
| 265103 – HUMERAL STEM, Ø8 L170 | In distribution | |
| 265162 – CANCELLOUS BONE SCREW, Ø5,5 L34 | In distribution | |
| 265155 – CEMENTLESS METAL-BACK GLENOID BASE, S48 | In distribution | |
| 265137 – CEMENTED GLENOID, S44 | In distribution | |
| 265149 – STD HUMERAL INSERT, Ø42 / H10 | In distribution | |
| 265143 – STD HUMERAL INSERT, Ø36 / H10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 442 |
| Reunion | Stryker GmbH | 321 |
| DJO Surgical | Encore Medical, L.P. | 266 |
| SMR Shoulder | Limacorporate | 209 |
| Tornier Flex Shoulder System | Tornier Inc. | 187 |
| Anatomical Shoulder™ | Zimmer, Inc. | 166 |
| Arthrex® | Arthrex, Inc. | 154 |
| Comprehensive Shoulder System | Biomet Orthopedics | 111 |
| Flex Shoulder System | Tornier Inc. | 109 |
| Aequalis™ PerFORM+ | Tornier Inc. | 108 |
| Aequalis™ Ascend™ Flex | Tornier Inc. | 102 |
| Anatomic Shoulder Prosthesis | Medacta International SA | 90 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093599 | 2010-11-24 |
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.