CS2 Acetabular System

Drill, Bayonet, 3.2mm, 45mm

Registry build 21.09.26
10manufacturers in China registered for this device type
32catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Zhejiang (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KIJ
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
Shaanxi Ansen Medical Technology Development Co., Ltd. Xi’An Shaanxi Contract manufacturer 7
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Jiangsu Saikang Medical Equipment Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 34
Jiangsu Yongfa Medical Equipment Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 33
Shanghai NO. 2 Medical College Duhang Medical Equipment Factory Shanghai Shanghai Contract manufacturer 32
Denjoy Dental Co., Ltd. Changsha Hunan Contract manufacturer 17
Gavin Biotechnology Co., Ltd. Jinzhong Shanxi Manufacturer 16
Suzhou Number WIN Medical Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 16

Record

Regulatory record for CS2 Acetabular System
Listed by Shalby Advanced Technologies, Inc., United States
FDA product code KIJ
Device type Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Device class Class 1
Regulation 21 CFR 878.4820
Establishment Contract manufacturer, Contract steriliser, Manufacturer
Premarket notification Exempt
Record published 2025-05-20

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 CS2 Acetabular System
Catalogue number Size Status
2801-0-4532 Drill, Bayonet, 3.2mm, 45mm In distribution
2801-0-3532 Drill, Bayonet, 3.2mm, 35mm In distribution
1800-2-1242 Reamer, Acetabular, 42mm In distribution
1800-2-1259 Reamer, Acetabular, 59mm In distribution
1800-2-1245 Reamer, Acetabular, 45mm In distribution
2801-0-5632 Drill, Bayonet, 3.2mm, 56mm In distribution
1800-2-1248 Reamer, Acetabular, 48mm In distribution
1800-2-1264 Reamer, Acetabular, 64mm In distribution
1800-2-1255 Reamer, Acetabular, 55mm In distribution
1800-2-1260 Reamer, Acetabular, 60mm In distribution
1800-2-1249 Reamer, Acetabular, 49mm In distribution
1800-2-1254 Reamer, Acetabular, 54mm In distribution
1800-2-1256 Reamer, Acetabular, 56mm In distribution
1800-2-1241 Reamer, Acetabular, 41mm In distribution
1800-2-1257 Reamer, Acetabular, 57mm In distribution
1800-2-1252 Reamer, Acetabular, 52mm In distribution
1800-2-1251 Reamer, Acetabular, 51mm In distribution
1800-2-1262 Reamer, Acetabular, 62mm In distribution
1800-2-1261 Reamer, Acetabular, 61mm In distribution
1800-2-1268 Reamer, Acetabular, 68mm In distribution
1800-2-1263 Reamer, Acetabular, 63mm In distribution
1800-2-1267 Reamer, Acetabular, 67mm In distribution
1800-2-1247 Reamer, Acetabular, 47mm In distribution
1800-2-1265 Reamer, Acetabular, 65mm In distribution
1800-2-1250 Reamer, Acetabular, 50mm In distribution
1800-2-1246 Reamer, Acetabular, 46mm In distribution
1800-2-1244 Reamer, Acetabular, 44mm In distribution
1800-2-1243 Reamer, Acetabular, 43mm In distribution
1800-2-1258 Reamer, Acetabular, 58mm In distribution
1800-2-1240 Reamer, Acetabular, 40mm In distribution
1800-2-1266 Reamer, Acetabular, 66mm In distribution
1800-2-1253 Reamer, Acetabular, 53mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Stainless Steel Guide Wires Orthopediatrics, Corp 76
OsteoMed Osteomed 36
Medinaut MAX Imedicom Co., Ltd. 25
MicroAire® Microaire Surgical Instruments LLC 20
R&D Batteries, Inc. R & D Batteries, Inc. 18
Pediatric Nailing Platform | Tibia Orthopediatrics, Corp 17
PNP Tibia Orthopediatrics, Corp 14
EZImpactor Imedicom Co., Ltd. 13
Insurgical, Inc. Insurgical, Inc. 12
Response Spine System Orthopediatrics, Corp 12
3P Hip System Orthopediatrics, Corp 12
Global Steptech Depuy (Ireland) 12

Showing 12 of 64. All products under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

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