Arthrex®
HI-FLO Shth SET FOR 4MM Stryker AR-Scope
21manufacturers in China registered for this device type
109catalogue numbers in this listing
27510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (7), Jiangsu (6), Guangdong (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
Showing 12 of 21. All 21 manufacturers in China registered for Arthroscope
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | HRX |
| Device type | Arthroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-02-15 |
| Record revised | 2024-02-02 (version 26) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 10, box of 20, box of 8, box of 25 |
| Distribution end date | 2021-03-11 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-3350-1930 | In distribution | |
| AR-6431 | In distribution | |
| AR-3200-70 | In distribution | |
| AR-3350-5070 | In distribution | |
| AR-3045AWR | In distribution | |
| AR-S3350-6330-181 | In distribution | |
| AR-3211 | In distribution | |
| AR-3350-5430 | In distribution | |
| AR-S3350-6330-130 | In distribution | |
| AR-3130AW | In distribution | |
| AR-3070AW | In distribution | |
| AR-3355-3030 | In distribution | |
| AR-3355-4000 | In distribution | |
| AR-S7305-020-260 | In distribution | |
| AR-3037S | In distribution | |
| AR-3000AW | In distribution | |
| AR-3355-2730 | In distribution | |
| IR0070 | In distribution | |
| AR-3350-3570 | In distribution | |
| AR-6482 | In distribution | |
| IR0030 | In distribution | |
| AR-3030AS | In distribution | |
| AR-3355-4030R | In distribution | |
| AR-3355-5470 | In distribution | |
| AR-3350-4030R | In distribution | |
| AR-6421 | In distribution | |
| AR-3355-3070 | In distribution | |
| AR-S3350-7030-130 | In distribution | |
| AR-S4100-100-000 | In distribution | |
| AR-S3350-7030-181 | In distribution | |
| AR-3355-2430 | In distribution | |
| AR-3350-2470 | In distribution | |
| AR-6476 | In distribution | |
| AR-3030AN | In distribution | |
| AR-6220 | In distribution | |
| AR-3350-3070 | In distribution | |
| AR-6410 | In distribution | |
| AR-6475S | In distribution | |
| AR-3030AW | In distribution | |
| AR-3350-5470 | In distribution | |
| AR-3350-2730 | In distribution | |
| AR-3355-5430 | In distribution | |
| AR-3350-4070 | In distribution | |
| AR-3350-4031 | In distribution | |
| AR-6480-SF | In distribution | |
| AR-3350-5030 | In distribution | |
| IR0104 | In distribution | |
| AR-6411 | In distribution | |
| AR-6435 | In distribution | |
| AR-S7305-035D-330 | In distribution | |
| AR-3200-30 | In distribution | |
| AR-3350-2770 | In distribution | |
| AR-3030AWR | In distribution | |
| AR-S3350-7030-215 | In distribution | |
| IR2030 | In distribution | |
| AR-S1342-025-310 | In distribution | |
| AR-6415 | In distribution | |
| AR-S7324-030-310 | In distribution | |
| AR-S7323-030V-310 | In distribution | |
| AR-3350-5230 | In distribution | |
| AR-3170AW | In distribution | |
| AR-3355-4030H | In distribution | |
| AR-3045AW | In distribution | |
| AR-3037-01 | In distribution | |
| AR-3355-4030 | In distribution | |
| AR-6413 | In distribution | |
| AR-3350-5270 | In distribution | |
| AR-3350-2430 | In distribution | |
| AR-3355-4031 | In distribution | |
| AR-3350-2930 | In distribution | |
| AR-3355-2470 | In distribution | |
| AR-3355-5230 | In distribution | |
| AR-6425 | In distribution | |
| AR-S7323-030-310 | In distribution | |
| AR-S3350-1015-139 | In distribution | |
| AR-6483 | In distribution | |
| AR-6475 | In distribution | |
| AR-6436 | In distribution | |
| AR-S3350-7015-181 | In distribution | |
| AR-3350-3530 | In distribution | |
| AR-3070AWR | In distribution | |
| AR-3350-4030 | In distribution | |
| AR-S3350-6315-181 | In distribution | |
| AR-3355-4071 | In distribution | |
| AR-S3350-6330-215 | In distribution | |
| AR-3350-4070H | In distribution | |
| IR2100 | In distribution | |
| AR-6485 | In distribution | |
| AR-S1342-030-260 | In distribution | |
| IR4100 | In distribution | |
| AR-3350-3030 | In distribution | |
| AR-3210-02 | In distribution | |
| AR-6200 | In distribution | |
| AR-3355-4070H | In distribution | |
| AR-3350-4030H | In distribution | |
| AR-S3350-7015-130 | In distribution | |
| AR-3355-2770 | In distribution | |
| AR-3355-5270 | In distribution | |
| AR-S7305-035-330 | In distribution | |
| IR4030 | In distribution | |
| AR-3350-4071 | In distribution | |
| AR-3355-4070 | In distribution | |
| AR-6430 | In distribution | |
| AR-6495 | In distribution | |
| AR-6215 | In distribution | |
| AR-6420 | In distribution | |
| AR-6480 | In distribution | |
| AR-6480-SR | Withdrawn | |
| RAR-3130AWS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 299 |
| Arthroscope | Karl Storz GmbH & Co. KG | 278 |
| Conmed/Linvatec | Provision | 265 |
| Arthroscope | Smith & Nephew, Inc. | 255 |
| Medline | Medline Industries, Inc. | 205 |
| Arthroscope | Sterilmed, Inc. | 184 |
| Sustainable Technologies | Provision | 150 |
| Medline Renewal | Medline Industries, Inc. | 123 |
| Stryker | Provision | 113 |
| Arthrex | Provision | 109 |
| Eberle | Eberle GmbH & Co. KG | 92 |
| Arcadia™ | Merit Medical Systems, Inc. | 63 |
Showing 12 of 567. All products under Arthroscope
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243602 | 2025-05-16 |
| K083707 | 2009-08-03 |
| K024291 | 2003-03-20 |
| K030096 | 2003-03-18 |
| K943943 | 1994-12-20 |
| K921119 | 1994-04-15 |
| K940075 | 1994-04-15 |
| K930152 | 1994-03-11 |
| K926212 | 1994-01-31 |
| K926303 | 1994-01-26 |
| K926193 | 1993-03-16 |
| K926062 | 1993-03-16 |
| K925996 | 1993-03-16 |
| K926111 | 1993-03-16 |
| K925884 | 1993-03-04 |
| K925954 | 1993-03-04 |
| K925458 | 1993-03-04 |
| K925456 | 1993-03-04 |
| K925814 | 1993-03-04 |
| K925995 | 1993-03-04 |
| K925986 | 1993-03-04 |
| K925457 | 1993-03-04 |
| K923142 | 1993-02-09 |
| K925455 | 1993-02-08 |
| K922890 | 1993-02-08 |
| K921823 | 1992-10-15 |
| K915721 | 1992-03-19 |
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.