Arthrex®
3.0mm HybridVal Kreu.Comp.ScrewSysmCaddy
110manufacturers in China registered for this device type
1,686catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (31), Jiangsu (27), Guangdong (20). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
Showing 12 of 110. All 110 manufacturers in China registered for Instrument, Manual, Surgical, General Use
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | MDM |
| Device type | Instrument, Manual, Surgical, General Use |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-10-10 |
| Record revised | 2026-08-03 (version 12) |
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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 5, box of 10, box of 15, box of 12 |
| Distribution end date | 2025-05-26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AR-6576S-C | In distribution | ||
| AR-2820-35 | In distribution | ||
| AR-1250Z | In distribution | ||
| AR-1510HR | In distribution | ||
| AR-1800-07 | In distribution | ||
| AR-8911G-06 | In distribution | ||
| AR-8656-20 | In distribution | ||
| AR-1510S | In distribution | ||
| AR-8737-02 | 6 | In distribution | |
| AR-13990N | In distribution | ||
| AR-7000-08 | In distribution | ||
| AR-4059 | In distribution | ||
| AR-9200-25 | In distribution | ||
| AR-1927PBS | In distribution | ||
| AR-13308 | In distribution | ||
| AR-01-05-008 | In distribution | ||
| AR-8933GVN | In distribution | ||
| AR-11791F | In distribution | ||
| AR-2523 | In distribution | ||
| AR-8943-43 | In distribution | ||
| AR-18700-18 | In distribution | ||
| AR-8924C-02 | In distribution | ||
| AR-8943-26 | In distribution | ||
| AR-11392F | In distribution | ||
| AR-8963-18 | In distribution | ||
| AR-2650CT | In distribution | ||
| AR-7799-3-0 | In distribution | ||
| SP-0527 | In distribution | ||
| AR-9099C-02 | In distribution | ||
| AR-8949DG | In distribution | ||
| AR-8954-17 | In distribution | ||
| SP-643-2 | In distribution | ||
| AR-7224 | In distribution | ||
| AR-8924C | In distribution | ||
| AR-12990N | In distribution | ||
| AR-8771W | In distribution | ||
| AR-8943C-SC1 | In distribution | ||
| AR-2522 | In distribution | ||
| AR-2810R-30-3 | In distribution | ||
| AR-8943-03 | In distribution | ||
| AR-8933KS | In distribution | ||
| AR-9231-02 | In distribution | ||
| AR-6592-08-40-1 | In distribution | ||
| AR-6592-08-90 | In distribution | ||
| AR-8170-35DC | In distribution | ||
| AR-9510-07 | In distribution | ||
| AR-1510FPR | In distribution | ||
| AR-7000-07 | In distribution | ||
| AR-8943C-SC | In distribution | ||
| AR-13436 | In distribution | ||
| AR-9510-08 | In distribution | ||
| AR-13303-2.4 | 6 | In distribution | |
| AR-9501HC-2 | In distribution | ||
| AR-8941LS-APC | In distribution | ||
| AR-1510PTL | In distribution | ||
| AR-2382S | In distribution | ||
| AR-8957C | In distribution | ||
| AR-1217S | In distribution | ||
| AR-2180M | In distribution | ||
| AR-8950C-24 | In distribution | ||
| AR-2655CT | In distribution | ||
| AR-12000F | In distribution | ||
| AR-2265 | In distribution | ||
| AR-18700-61 | In distribution | ||
| AR-7700S | In distribution | ||
| AR-11700NRF | In distribution | ||
| AR-8954-13 | In distribution | ||
| AR-S1000-C3 | In distribution | ||
| AR-601-TTR4 | In distribution | ||
| AR-4077M-14 | In distribution | ||
| AR-13250 | In distribution | ||
| AR-4092CM-17 | In distribution | ||
| AR-8662 | In distribution | ||
| AR-5102 | In distribution | ||
| AR-13427-01 | In distribution | ||
| AR-601-PB09 | In distribution | ||
| AR-8737C-02 | In distribution | ||
| AR-8933HVCLC | In distribution | ||
| AR-601-TTL6 | In distribution | ||
| AR-9202-29H | In distribution | ||
| AR-601-C2 | In distribution | ||
| AR-8656-32 | In distribution | ||
| AR-1591 | In distribution | ||
| AR-8916-17 | In distribution | ||
| AR-4158C | In distribution | ||
| SP-623-72 | In distribution | ||
| AR-8656-33 | In distribution | ||
| AR-15310F | In distribution | ||
| AR-8170-50DC | In distribution | ||
| AR-2855 | In distribution | ||
| AR-13303-2.4-1S | In distribution | ||
| AR-8850SC | In distribution | ||
| AR-8919G-01 | In distribution | ||
| AR-9095C-L | In distribution | ||
| AR-30050F | In distribution | ||
| AR-13303-3.0 | 6 | In distribution | |
| AR-8714S | In distribution | ||
| AR-7650C-01 | In distribution | ||
| AR-8656C | In distribution | ||
| AR-4077S-17 | In distribution | ||
| AR-11100F | In distribution | ||
| AR-7050 | In distribution | ||
| AR-1817C | In distribution | ||
| AR-9943S-PC | In distribution | ||
| AR-8717C | In distribution | ||
| AR-1254 | 6 | In distribution | |
| AR-1342-30 | In distribution | ||
| AR-8916C-07 | In distribution | ||
| AR-8640 | In distribution | ||
| AR-8170 | In distribution | ||
| AR-8717G-03 | In distribution | ||
| AR-1949H-2.4 | In distribution | ||
| AR-18700CS-03 | In distribution | ||
| AR-9954-06 | In distribution | ||
| AR-4080S-17 | In distribution | ||
| AR-13411-02 | In distribution | ||
| AR-9128RF-01 | In distribution | ||
| AR-11750SR | In distribution | ||
| AR-11900NRF | In distribution | ||
| AR-12974SRF | In distribution | ||
| AR-8750C | In distribution | ||
| AR-8950C-CM | In distribution | ||
| AR-8738C | In distribution | ||
| AR-13500NRF | In distribution | ||
| AR-1240-07 | In distribution | ||
| AR-9938-02 | In distribution | ||
| AR-1322DSC | In distribution | ||
| AR-1510FD-30 | In distribution | ||
| AR-11240F | In distribution | ||
| AR-11900SRF | In distribution | ||
| AR-8970C | In distribution | ||
| AR-1909R | In distribution | ||
| AR-9260-37 | In distribution | ||
| AR-601-TTR6 | In distribution | ||
| AR-4200C | In distribution | ||
| AR-15810F | In distribution | ||
| AR-13240K | 6 | In distribution | |
| AR-6592-08-20 | In distribution | ||
| AR-8850S | In distribution | ||
| AR-6477-01 | In distribution | ||
| AR-8964C-02 | In distribution | ||
| AR-11500NRF | In distribution | ||
| AR-4080M-17 | In distribution | ||
| AR-6592-10-30 | In distribution | ||
| AR-13998C | In distribution | ||
| AR-8941C-1 | In distribution | ||
| AR-6592-10-50 | In distribution | ||
| AR-9511RG-R | In distribution | ||
| AR-7755 | In distribution | ||
| AR-9204-07 | In distribution | ||
| AR-8944DH | In distribution | ||
| AR-9202-34H | In distribution | ||
| AR-2923DS | In distribution | ||
| AR-1976 | In distribution | ||
| AR-1420 | In distribution | ||
| AR-9954C-SC-VCL | In distribution | ||
| AR-8916C-22 | In distribution | ||
| AR-9954-07 | In distribution | ||
| AR-8964-18 | In distribution | ||
| AR-8738C-02 | In distribution | ||
| AR-613-C2 | In distribution | ||
| AR-12540W | In distribution | ||
| AR-6655 | In distribution | ||
| AR-11810SRF | In distribution | ||
| AR-601-TRRM | In distribution | ||
| AR-14003C | In distribution | ||
| AR-18700-57 | In distribution | ||
| AR-9165K | In distribution | ||
| AR-9665C-RAC | In distribution | ||
| AR-4069 | In distribution | ||
| AR-7710 | In distribution | ||
| AR-7000SC-1 | In distribution | ||
| AR-7001-10-15 | In distribution | ||
| AR-2519RC | In distribution | ||
| AR-7001-10-10 | In distribution | ||
| AR-9261-05 | In distribution | ||
| AR-623-40 | In distribution | ||
| AR-5103 | In distribution | ||
| AR-1344SE-30 | In distribution | ||
| AR-9095C-03 | In distribution | ||
| AR-5100C-01 | In distribution | ||
| AR-11391 | In distribution | ||
| AR-9095C-02 | In distribution | ||
| AR-1920CPB | In distribution | ||
| AR-8950C-16 | In distribution | ||
| AR-11241XLF | In distribution | ||
| AR-1775 | In distribution | ||
| AR-1926MC | In distribution | ||
| AR-1417 | In distribution | ||
| AR-13981P | In distribution | ||
| AR-8655-14 | In distribution | ||
| AR-13960SRF | In distribution | ||
| AR-601-PB07 | In distribution | ||
| AR-9510-12 | In distribution | ||
| AR-12550F | In distribution | ||
| AR-13417-02 | In distribution | ||
| AR-8946C-SC | In distribution | ||
| AR-8170-35L | In distribution | ||
| AR-8656-03 | In distribution | ||
| AR-601-CLMB | In distribution | ||
| AR-13995N | In distribution | ||
| AR-9231-01PP | In distribution | ||
| AR-1978-11MP | In distribution | ||
| AR-9099C-01-L | In distribution | ||
| AR-8974T | In distribution | ||
| AR-1510GTS | In distribution | ||
| AR-2256R | In distribution | ||
| AR-8941-7 | In distribution | ||
| AR-1259 | In distribution | ||
| AR-6592-08-30A | In distribution | ||
| AR-9953-03 | In distribution | ||
| AR-S8720-DG-H | In distribution | ||
| AR-6592-06-20 | In distribution | ||
| AR-9215-5 | In distribution | ||
| AR-613-50 | 4 | In distribution | |
| AR-8104 | In distribution | ||
| AR-8671H | In distribution | ||
| AR-16970SRF | In distribution | ||
| AR-1342H-15 | In distribution | ||
| AR-8737-05S | In distribution | ||
| AR-18700CS | In distribution | ||
| AR-9943C-SC1 | In distribution | ||
| AR-1209S | In distribution | ||
| AR-1938DS | In distribution | ||
| AR-8737C-01 | In distribution | ||
| AR-8943-01S | In distribution | ||
| AR-2526-01 | In distribution | ||
| AR-13600SRF | In distribution | ||
| AR-11440F | In distribution | ||
| AR-12580W | In distribution | ||
| AR-8655-02 | In distribution | ||
| AR-8943-17 | In distribution | ||
| AR-11044F | In distribution | ||
| AR-4083L-17 | In distribution | ||
| AR-1005E | In distribution | ||
| AR-9200-18 | In distribution | ||
| AR-1675C | In distribution | ||
| AR-8170-75DS | In distribution | ||
| AR-8935CLC | In distribution | ||
| AR-9510RG-5C | In distribution | ||
| AR-603-85 | In distribution | ||
| AR-11600NRF | In distribution | ||
| AR-13995N-1 | In distribution | ||
| AR-1510F-02 | In distribution | ||
| AR-3105C | In distribution | ||
| AR-4092CS-14 | In distribution | ||
| AR-8963C-04 | In distribution | ||
| AR-4085X-20 | In distribution | ||
| AR-8660 | In distribution | ||
| AR-9260-40 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TSI | Tedan Surgical Innovations, L.L.C. | 1,181 |
| Medfix | Medfix International, LLC | 514 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 446 |
| Fentex | Fentex medical GmbH | 407 |
| Millennium | Avalign Technologies, Inc. | 337 |
| Synergetics | Synergetics USA, Inc. | 312 |
| American Medicals | American Medicals | 298 |
| gSource | Gsource, LLC. | 291 |
| Life Instruments | Life Instrument Corp. | 274 |
| Ambler Surgical | Ambler Surgical, LLC | 272 |
| Instrument, Manual, Surgical, General Use | Karl Storz GmbH & Co. KG | 261 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 232 |
Showing 12 of 1,364. All products under Instrument, Manual, Surgical, General Use
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Arthrex, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | The devices may be packaged with the wrong reamer size. | 123 pieces |
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.