Modal Total Hip System

Acetabular Shell, Cluster Hole Sz 66

Registry build 21.09.26
15manufacturers in China registered for this device type
126catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Shanghai (3), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LZO
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
APS Materials Suzhou Suzhou Jiangsu Contract manufacturer 18
Xian Airfoil Technology Co., Ltd. Xian Shaanxi Contract manufacturer 8
Lincotek (Wuxi) Co., Ltd. Wuxi Jiangsu Contract manufacturer 7
b-ONE Medical (Beijing) Co., Ltd. Beijing Beijing Contract manufacturer 7
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70

Showing 12 of 15. All 15 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Record

Regulatory record for Modal Total Hip System
Listed by Modal Manufacturing LLC
FDA product code LZO
Device type Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class Class 2
Regulation 21 CFR 888.3353
510(k) K143314
Record published 2018-07-01
Record revised 2020-12-21 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Modal Total Hip System
Catalogue number Size Status
M-1435-2803 In distribution
M-1500-1005 In distribution
M-1400-0048 In distribution
M-1400-0600 In distribution
M-1125-1500 In distribution
M-1200-0066 In distribution
M-1300-3203 In distribution
M-1500-1007 In distribution
M-1300-2801 In distribution
M-1325-3604 In distribution
M-1200-0062 In distribution
M-1500-1006 In distribution
M-1400-1125 In distribution
M-1210-0064 In distribution
M-1400-0060 In distribution
M-1100-1250 In distribution
M-1400-0058 In distribution
M-1400-0062 In distribution
M-1300-3601 In distribution
M-1500-1016 In distribution
M-1400-1250 In distribution
M-1210-0048 In distribution
M-1100-2250 In distribution
M-1300-2804 In distribution
M-1410-2800 In distribution
M-1410-3600 In distribution
M-1300-3604 In distribution
M-1410-3200 In distribution
M-1500-1001 In distribution
M-1400-1500 In distribution
M-1100-0750 In distribution
M-1200-0052 In distribution
M-1500-1014 In distribution
M-1410-4000 In distribution
M-1400-0046 In distribution
M-1200-0050 In distribution
M-EBS-6520 In distribution
M-EBS-6530 In distribution
M-1125-0875 In distribution
M-1500-3601 In distribution
M-1300-3603 In distribution
M-1325-2802 In distribution
M-EBS-6535 In distribution
M-1325-3601 In distribution
M-1400-0064 In distribution
M-1125-1250 In distribution
M-1210-0050 In distribution
M-1100-1500 In distribution
M-1210-0052 In distribution
M-1300-3204 In distribution
M-1500-1009 In distribution
M-1125-2250 In distribution
M-EBS-6515 In distribution
M-1200-0064 In distribution
M-1325-3202 In distribution
M-1300-3602 In distribution
M-EBS-6540 In distribution
M-1325-3603 In distribution
M-1500-1008 In distribution
M-1210-0066 In distribution
M-1200-0046-01 In distribution
M-1325-2801 In distribution
M-1500-4001 In distribution
M-1400-2000 In distribution
M-1125-2000 In distribution
M-1435-2802 In distribution
M-1125-1125 In distribution
M-1400-0052 In distribution
M-1100-1375 In distribution
M-1400-1000 In distribution
M-1200-0056 In distribution
M-1435-2804 In distribution
M-1300-3201 In distribution
M-1200-0058 In distribution
M-1500-3201 In distribution
M-1210-0058 In distribution
M-1500-1011 In distribution
M-1125-1375 In distribution
M-1100-0875 In distribution
M-1400-0068 In distribution
M-1500-1013 In distribution
M-1200-0060 In distribution
M-1210-0056 In distribution
M-1200-0054 In distribution
M-1200-0048 In distribution
M-1210-0068 In distribution
M-1400-0750 In distribution
M-1125-1000 In distribution
M-1325-3204 In distribution
M-1210-0062 In distribution
M-EBS-6525 In distribution
M-1200-0046 In distribution
M-EBS-6545 In distribution
M-1400-2250 In distribution
M-1425-0722 In distribution
M-1100-2000 In distribution
M-1210-0060 In distribution
M-1325-3602 In distribution
M-1325-2803 In distribution
M-1400-0050 In distribution
M-1300-2802 In distribution
M-1500-1015 In distribution
M-1300-2803 In distribution
M-1400-0622 In distribution
M-1100-1125 In distribution
M-1100-0600 In distribution
M-1300-3202 In distribution
M-1500-1004 In distribution
M-1500-1002 In distribution
M-1325-3203 In distribution
M-1500-1012 In distribution
M-1200-0068 In distribution
M-1125-0750 In distribution
M-1400-0054 In distribution
M-1500-1003 In distribution
M-1400-0875 In distribution
M-1400-0056 In distribution
M-1100-1000 In distribution
M-1500-2801 In distribution
M-1210-0054 In distribution
M-1210-0046 In distribution
M-1500-1017 In distribution
M-1400-1375 In distribution
M-1500-1010 In distribution
M-1325-3201 In distribution
M-1400-0066 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Libertas Maxx Orthopedics Inc. 1,832
Redapt Smith & Nephew, Inc. 326
Bencox Hip System Corentec Co., Ltd. 295
M-Vizion Femoral Revision System Medacta International SA 289
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Zimmer, Inc. 280
Profemur® Microport Orthopedics Inc. 229
DJO Surgical Encore Medical, L.P. 162
Instrument Howmedica Osteonics Corp 152
Alteon Exactech, Inc. 151
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Exactech, Inc. 136
Resolve Modular Revision Hip Stem United Orthopedic Corp. 136
Wagner SL Revision® Zimmer, Inc. 133

Showing 12 of 691. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, 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