Aptus

Impl.Cont. Hand 2.0/2.3 Compr. & TriLock

Registry build 21.09.26
105manufacturers in China registered for this device type
588catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FSM
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Mobility Source Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 26
Guangdong Shunde LQX Health Technology Inc. Foshan Guangdong Contract manufacturer 24

Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument

Record

Regulatory record for Aptus
Listed by Medartis Inc., United States
FDA product code FSM
Device type Tray, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K243610
Record published 2023-02-24
Record revised 2024-11-01 (version 3)

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, expiry date, manufacturing date, serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Aptus
Catalogue number Size Status
A-0860.1 In distribution
A-6604.051 In distribution
A-6025 In distribution
A-0854.21 In distribution
A-6505 In distribution
A-6604.060 In distribution
A-6095.68 In distribution
A-6095.05 In distribution
A-6531 In distribution
A-6517 In distribution
A-6095.65 In distribution
A-6604.122 In distribution
A-6076.06 In distribution
A-6501.14 In distribution
A-6603.023 In distribution
A-6572 In distribution
A-6604.051 In distribution
A-6602.049 In distribution
A-6099.07 In distribution
A-6501.07 In distribution
A-6099.06 In distribution
A-0881 In distribution
A-0732 In distribution
A-6095.13 In distribution
A-6602.056 In distribution
A-0734 In distribution
A-6602.075 In distribution
A-6095.76 In distribution
A-6603.004 In distribution
A-6601.009 In distribution
A-6590 In distribution
A-0760 In distribution
A-6533 In distribution
A-6604.060 In distribution
A-0856.20 In distribution
A-6602.059 In distribution
A-6622 In distribution
A-6024 In distribution
A-0844.10 In distribution
A-6601.002 In distribution
A-6095.73 In distribution
A-6573 In distribution
A-6604.110 In distribution
A-6501 In distribution
A-6602.026 In distribution
A-6552 In distribution
A-6602.028 In distribution
A-6095.74 In distribution
A-6604.116 In distribution
A-6604.231 In distribution
A-6603.026 In distribution
A-6009 In distribution
A-0849.20 In distribution
A-6602.016 In distribution
A-6601.014 In distribution
A-6010.18 In distribution
A-6095.77 In distribution
A-6605.007 In distribution
A-6603.052 In distribution
A-0894 In distribution
A-6621 In distribution
A-6603.053 In distribution
A-6010.16 In distribution
A-6601.011 In distribution
A-0772 In distribution
A-6603.521 In distribution
A-6604.225 In distribution
A-6603.011 In distribution
A-0854.11.1 In distribution
A-6610.60 In distribution
A-0761 In distribution
A-0716 In distribution
A-6602.021 In distribution
A-6603.721 In distribution
A-6601.005 In distribution
A-6530 In distribution
A-6602.005 In distribution
A-6604.103 In distribution
A-6602.070 In distribution
A-0854.21.1 In distribution
A-6602.017 In distribution
A-6601.003 In distribution
A-6501 In distribution
A-6095.66 In distribution
A-6574 In distribution
A-6602.016 In distribution
A-6551 In distribution
A-6602.065 In distribution
A-6604.050 In distribution
A-6604.106 In distribution
A-6604.161 In distribution
A-6604.147 In distribution
A-6010.12 In distribution
A-0859.10 In distribution
A-0877 In distribution
A-6604.052 In distribution
A-6602.024 In distribution
A-6601.012 In distribution
A-6095.73 In distribution
A-6603.521 In distribution
A-6603.042 In distribution
A-6501.12 In distribution
A-6026 In distribution
A-6508 In distribution
A-6585 In distribution
A-6575 In distribution
A-6602.051 In distribution
A-6538 In distribution
A-6602.025 In distribution
A-6513 In distribution
A-6601.014 In distribution
A-0853.20 In distribution
A-0853.10 In distribution
A-6095.77 In distribution
A-6095.13 In distribution
A-6570 In distribution
A-6604.145 In distribution
A-6601.004 In distribution
A-6604.233 In distribution
A-0510 In distribution
A-0895 In distribution
A-6602.005 In distribution
A-6604.912 In distribution
A-0853.20.1 In distribution
A-6530 In distribution
A-6601.012 In distribution
A-0762 In distribution
A-6602.013 In distribution
A-6602.021 In distribution
A-6600.006 In distribution
A-6604.113 In distribution
A-6600.004 In distribution
A-6623 In distribution
A-0852.10 In distribution
A-6507 In distribution
A-0715 In distribution
A-6602.057 In distribution
A-6095.82 In distribution
A-6501.22 In distribution
A-6603.013 In distribution
A-6605.010 In distribution
A-6501.03 In distribution
A-6602.012 In distribution
A-0847.10 In distribution
A-6603.021 In distribution
A-0853.21.1 In distribution
A-6602.055 In distribution
A-6610.11 In distribution
A-6099.20 In distribution
A-6602.064 In distribution
A-6024 In distribution
A-6522 In distribution
A-6604.135 In distribution
A-6620 In distribution
A-6095.61 In distribution
A-6522 In distribution
A-6604.149 In distribution
A-6604.912 In distribution
A-6501.19 In distribution
A-6602.035 In distribution
A-6501.18 In distribution
A-6600.007 In distribution
A-6604.913 In distribution
A-6095.75 In distribution
A-6603.023 In distribution
A-6603.041 In distribution
A-6095.62 In distribution
A-6604.104 In distribution
A-0893 In distribution
A-0722 In distribution
A-6099.23 In distribution
A-6603.042 In distribution
A-0853.70.1 In distribution
A-6602.027 In distribution
A-6070.48 In distribution
A-6601.003 In distribution
A-6610.10 In distribution
A-6603.511 In distribution
A-6602.033 In distribution
A-6604.232 In distribution
A-6602.002 In distribution
A-6020 In distribution
A-6602.071 In distribution
A-6602.057 In distribution
A-6603.731 In distribution
A-6095.71 In distribution
A-6602.076 In distribution
A-6514 In distribution
A-6520 In distribution
A-6604.119 In distribution
A-6519 In distribution
A-6601.001 In distribution
A-0810.10 In distribution
A-0883 In distribution
A-0846.10 In distribution
A-0725 In distribution
A-6095.63 In distribution
A-6535 In distribution
A-6601.005 In distribution
A-6604.130 In distribution
A-6602.050 In distribution
A-6603.511 In distribution
A-6604.165 In distribution
S-6001 In distribution
A-6600.003 In distribution
A-6600.010 In distribution
A-6095.72 In distribution
A-6604.133 In distribution
A-6601.004 In distribution
A-6095.66 In distribution
A-6604.131 In distribution
A-6604.132 In distribution
A-6603.053 In distribution
A-6602.001 In distribution
A-6586 In distribution
A-6604.141 In distribution
A-0857.10 In distribution
A-6605.012 In distribution
A-6500 In distribution
A-6604.146 In distribution
A-0849.10 In distribution
A-6602.022 In distribution
A-0810.32 In distribution
A-6095.65 In distribution
A-6583 In distribution
A-6604.126 In distribution
A-6501.13 In distribution
A-0880.1 In distribution
A-6095.69 In distribution
A-6602.001 In distribution
A-0765 In distribution
A-6602.031 In distribution
A-6621 In distribution
A-6603.051 In distribution
A-6583 In distribution
A-6604.155 In distribution
A-6603.731 In distribution
A-6500 In distribution
A-0714 In distribution
A-6009 In distribution
A-6602.018 In distribution
A-6604.115 In distribution
A-6574 In distribution
A-0896 In distribution
A-6508 In distribution
A-6603.014 In distribution
A-6525 In distribution
A-6602.050 In distribution
A-6099.15 In distribution
A-0851.30 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IMS HU-Friedy MFG Co., LLC 2,710
Tray, Surgical, Instrument Synthes Gmbh 1,052
Tray, Surgical, Instrument Medtronic Sofamor Danek, Inc. 1,012
Hu-Friedy MFG Co., LLC. HU-Friedy MFG Co., LLC 666
Acumed Acumed LLC 566
Aesculap Aesculap AG 532
Sklar Sklar Corporation 465
Hu-Friedy HU-Friedy MFG Co., LLC 438
Nordent Manufacturing Inc Nordent Manufacturing Inc 429
Level ONE KLS-Martin L.P. 341
Bahadir USA Bahadir USA LLC 300
Devon Cardinal Health 254

Showing 12 of 3,212. All products under Tray, Surgical, Instrument

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