Surgical Instrument

51 catalogue numbers from C9Q.01010, listed by Osteonic Co., Ltd., South Korea, under Tray, Surgical, Instrument. 105 manufacturers in China are registered for this product code.

Registry build 21.09.26
105manufacturers in China registered for this device type
51catalogue 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 Surgical Instrument
Listed by Osteonic Co., Ltd., South Korea
FDA product code FSM
Device type Tray, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Manufacturer, Exporter
Premarket notification Exempt
Record published 2025-06-24

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 Surgical Instrument
Catalogue number Size Status
C9Q.01010 In distribution
Z1Y.01210 In distribution
Z1B.02010-ACE In distribution
Z1M.03010 In distribution
Z1A.03010 In distribution
Z1C.03010 In distribution
Z1C.02010 In distribution
Z1B.03010 In distribution
Z1F.50010 In distribution
Z1Y.01220 In distribution
Z1A.50010 In distribution
Z1Z.01040 In distribution
Y1L.03010 In distribution
Z1M.50010 In distribution
Z1Z.01030 In distribution
Z1Z.01050 In distribution
Z1Y.01310 In distribution
D9Q.01020 In distribution
Z1B.03010-AC In distribution
Z1B.50010-AC In distribution
Z1Y.50010 In distribution
Z1Z.03010 In distribution
Z1M.01010 In distribution
Z1Y.01320 In distribution
Z1Y.01410 In distribution
Z1A.01010 In distribution
Z1Y.03010 In distribution
Z1M.50020 In distribution
Z1Y.01110 In distribution
Z1B.02010 In distribution
Z1Z.02010 In distribution
Z1M.35010 In distribution
A9.0101 In distribution
Z1Z.01020 In distribution
Z1B.01010-ACE In distribution
Y1L.03020 In distribution
Z1Z.01010 In distribution
Z1A.02010 In distribution
Z1F.03010 In distribution
Z1B.50010 In distribution
Z1C.01010 In distribution
B1Q.0101 In distribution
Z1C.50010 In distribution
Z1Y.01120 In distribution
Z1B.01010 In distribution
Z1F.02010 In distribution
Z1C.20010 In distribution
Z1F.01010 In distribution
Z1M.03020 In distribution
Z1Y.02010 In distribution
Z1Z.50010 In distribution

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
Aptus Medartis Inc. 588
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

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