Prima

PRIMA - Anatomic Back Table Assembly Block Plus #6

Registry build 21.09.26
8manufacturers in China registered for this device type
67catalogue 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 Prima
Listed by Limacorporate, Italy
FDA product code HSD
Device type Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class Class 2
Regulation 21 CFR 888.3690
Record published 2022-03-17
Record revised 2024-02-07 (version 4)

Specifications

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 numbers for Prima
Catalogue number Size Status
9013.67.062 #2 In distribution
9013.67.186 #6 In distribution
9013.67.140 In distribution
9013.67.107 #7 In distribution
9013.67.193 In distribution
9013.67.055 LEFT In distribution
9013.67.063 #3 In distribution
9013.67.111 #1 In distribution
9013.67.421 #1 In distribution
9013.67.423 #3 In distribution
9013.67.061 #1 In distribution
9013.67.435 #6-7 In distribution
9013.67.144 #4 In distribution
9013.67.103 #3 In distribution
9013.67.422 #2 In distribution
9013.67.100 In distribution
9013.67.402 #2 In distribution
9013.67.401 #1 In distribution
9013.67.116 #6 In distribution
9013.67.143 #3 In distribution
9013.67.183 #3 In distribution
9013.67.066 #5 In distribution
9013.67.102 #2 In distribution
9013.67.113 #3 In distribution
9013.67.117 #7 In distribution
9013.67.182 #2 In distribution
9013.67.425 #5 In distribution
9013.67.142 #2 In distribution
9013.67.192 In distribution
9013.67.403 #3 In distribution
9013.67.147 #7 In distribution
9013.67.191 In distribution
9013.67.404 #4 In distribution
9013.67.112 #2 In distribution
9013.67.050 RIGHT In distribution
9013.67.187 #6 In distribution
9013.67.104 #4 In distribution
9013.67.106 #6 In distribution
9013.67.064 #4 In distribution
9013.67.114 #4 In distribution
9013.67.407 #7 In distribution
9013.67.406 #6 In distribution
9013.67.436 #1-5 Plus In distribution
9013.67.194 In distribution
9013.67.110 In distribution
9013.67.615 #5 In distribution
9013.67.184 #4 In distribution
9013.67.001 In distribution
9013.67.165 #5 In distribution
9013.67.185 #5 In distribution
9013.67.141 #1 In distribution
9013.67.426 #6 In distribution
9013.67.145 #5 In distribution
9013.67.146 #6 In distribution
9013.67.065 #5 In distribution
9013.67.005 In distribution
9013.67.105 #5 In distribution
9013.67.427 #7 In distribution
9013.67.020 In distribution
9013.67.181 #1 In distribution
9013.67.101 #1 In distribution
9013.67.405 #5 In distribution
9013.67.424 #4 In distribution
9013.67.067 #7 In distribution
9013.67.430 #1-5 In distribution
9013.67.188 In distribution
9013.67.115 #5 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