Arrow®

21 catalogue numbers from 265109 - CoCr CENTRED HUMERAL HEAD, Ø44 , listed by Fournitures Hospitalieres Industrie, United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Registry build 21.09.26
8manufacturers in China registered for this device type
21catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code HSD
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

Regulatory record for Arrow®
Listed by Fournitures Hospitalieres Industrie, United States
FDA product code HSD
Device type Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class Class 2
Regulation 21 CFR 888.3690
510(k) K093599
Record published 2015-10-24
Record revised 2018-07-06 (version 3)

Specifications

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 numbers for Arrow®
Catalogue number Size Status
265109 – CoCr CENTRED HUMERAL HEAD, Ø44 H16 In distribution
265129 – CoCr OFF-CENTRED HUMERAL HEAD, Ø48 H16 In distribution
265138 – CEMENTED GLENOID, S46 In distribution
265104 – HUMERAL STEM, Ø10 L125 In distribution
265131 – CoCr OFF-CENTRED HUMERAL HEAD, Ø48 H21 In distribution
265102 – HUMERAL STEM, Ø8 L120 In distribution
265121 – CoCr CENTRED HUMERAL HEAD, Ø52 H21 In distribution
265111 – CoCr CENTRED HUMERAL HEAD, Ø46 H16 In distribution
265125 – CoCr OFF-CENTRED HUMERAL HEAD, Ø44 H18 In distribution
265113 – CoCr CENTRED HUMERAL HEAD, Ø46 H21 In distribution
265107 – CoCr CENTRED HUMERAL HEAD, Ø40 H15 In distribution
267360 – HUMERAL STEM, Ø6 L100 In distribution
265123 – CoCr CENTRED HUMERAL HEAD, Ø54 H21 In distribution
265115 – CoCr CENTRED HUMERAL HEAD, Ø48 H18 In distribution
265117 – CoCr CENTRED HUMERAL HEAD, Ø50 H17 In distribution
265133 – CoCr OFF-CENTRED HUMERAL HEAD, Ø50 H19 In distribution
265106 – HUMERAL STEM, Ø14 L135 In distribution
265140 – CEMENTED GLENOID, S50 In distribution
265127 – CoCr OFF-CENTRED HUMERAL HEAD, Ø46 H18 In distribution
265119 – CoCr CENTRED HUMERAL HEAD, Ø50 H21 In distribution
265135 – CoCr OFF-CENTRED HUMERAL HEAD, Ø52 H19 In distribution

Same Product Code

Other products under the same FDA 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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer