Arthroscope
Shaver Blade Bonecutter Synovator W/Full Radius Inner Forest Green/Black
21manufacturers in China registered for this device type
184catalogue numbers in this listing
1510(k) clearance
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 | Sterilmed, Inc., United States |
|---|---|
| FDA product code | HRX |
| Device type | Arthroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Reprocessor, Specification developer, Manufacturer |
| 510(k) | K012536 |
| Record published | 2016-09-22 |
| Record revised | 2025-02-14 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-02-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SMI72200729 | Withdrawn | |
| LINH9119 | Withdrawn | |
| SMI7205319 | Withdrawn | |
| SMI7205326 | Withdrawn | |
| SMI7205330 | Withdrawn | |
| SMI7205324 | Withdrawn | |
| SMI7205345 | Withdrawn | |
| SMI7205306 | Withdrawn | |
| ARTAR-8550EX | Withdrawn | |
| SMI7205311 | Withdrawn | |
| SMI7205727 | Withdrawn | |
| LIN9246A | Withdrawn | |
| LINH9131 | Withdrawn | |
| STR375-637-000 | Withdrawn | |
| ARTAR-8550SR | Withdrawn | |
| LINC9944A | Withdrawn | |
| LIN9247A | Withdrawn | |
| LINC9254 | Withdrawn | |
| SMI7210751 | Withdrawn | |
| LINH9102 | Withdrawn | |
| LINMC9290 | Withdrawn | |
| SMI7205459 | Withdrawn | |
| ARTAR-8500EX | Withdrawn | |
| SMI72202530 | Withdrawn | |
| SMI7205318 | Withdrawn | |
| LINC9415 | Withdrawn | |
| STR375-544-000 | Withdrawn | |
| STR375-564-000 | Withdrawn | |
| ARTAR-8380ST | Withdrawn | |
| LINC9291 | Withdrawn | |
| LINH9111 | Withdrawn | |
| LINC9245 | Withdrawn | |
| LIN35ULT-ST-ZZ | Withdrawn | |
| STR375-747-000 | Withdrawn | |
| ARTAR-8550RBE | Withdrawn | |
| LINC9284 | Withdrawn | |
| ARTAR-8400OBE | Withdrawn | |
| STR375-950-112 | Withdrawn | |
| LIN9761A | Withdrawn | |
| SMI7210976 | Withdrawn | |
| SMI7205310 | Withdrawn | |
| SMI72202531 | Withdrawn | |
| STR375-952-000 | Withdrawn | |
| SMI72200725 | Withdrawn | |
| LINH9132 | Withdrawn | |
| ARTAR-8500BC | Withdrawn | |
| STR375-554-000 | Withdrawn | |
| SMI7205312 | Withdrawn | |
| STR375-941-200 | Withdrawn | |
| ARTAR-8380EX | Withdrawn | |
| LINC9962 | Withdrawn | |
| LINC9258 | Withdrawn | |
| SMI7205309 | Withdrawn | |
| LINC9102 | Withdrawn | |
| STR275-628-000 | Withdrawn | |
| ARTAR-8400DS | Withdrawn | |
| LINC9262 | Withdrawn | |
| STR275-647-000 | Withdrawn | |
| STR375-951-000 | Withdrawn | |
| SMI72200724 | Withdrawn | |
| STR375-543-000 | Withdrawn | |
| LIN9299A | Withdrawn | |
| STR375-562-000 | Withdrawn | |
| LINC9274 | Withdrawn | |
| STR375-565-000 | Withdrawn | |
| SMI7205669 | Withdrawn | |
| STR375-545-000 | Withdrawn | |
| LINH9122 | Withdrawn | |
| SMI7209065 | Withdrawn | |
| STR375-930-000 | Withdrawn | |
| SMI7205313 | Withdrawn | |
| ARTAR-8500RBE | Withdrawn | |
| STR375-950-012 | Withdrawn | |
| STR375-941-500 | Withdrawn | |
| STR275-562-000 | Withdrawn | |
| LINC9264 | Withdrawn | |
| SMI7205325 | Withdrawn | |
| STR375-546-000 | Withdrawn | |
| LINC9961 | Withdrawn | |
| ARTAR-8500TBT | Withdrawn | |
| STR375-940-012 | Withdrawn | |
| SMI3530 | Withdrawn | |
| LINC9255 | Withdrawn | |
| SMI7205331 | Withdrawn | |
| STR375-737-000 | Withdrawn | |
| SMI72203523 | Withdrawn | |
| LIN9297A | Withdrawn | |
| ARTAR-8380SR | Withdrawn | |
| LINC9248 | Withdrawn | |
| STR375-535-000 | Withdrawn | |
| SMI7209335 | Withdrawn | |
| LINC9242 | Withdrawn | |
| STR375-552-000 | Withdrawn | |
| ARTAR-8400BC | Withdrawn | |
| LINC9943A | Withdrawn | |
| SMI7205668 | Withdrawn | |
| SMI7205328 | Withdrawn | |
| STR375-950-000 | Withdrawn | |
| ARTAR-8500OBE | Withdrawn | |
| SMI7206011 | Withdrawn | |
| SMI7205316 | Withdrawn | |
| STR375-647-000 | Withdrawn | |
| LINC9253 | Withdrawn | |
| STR275-941-012 | Withdrawn | |
| LINH9133 | Withdrawn | |
| SMI7205327 | Withdrawn | |
| SMI7205308 | Withdrawn | |
| STR375-757-000 | Withdrawn | |
| LINC9960 | Withdrawn | |
| SMI72200095 | Withdrawn | |
| STR375-950-100 | Withdrawn | |
| LINH9110 | Withdrawn | |
| ARTAR-8380SW | Withdrawn | |
| ARTAR-8400SR | Withdrawn | |
| LINC9298A | Withdrawn | |
| LIN9263A | Withdrawn | |
| SMI7205315 | Withdrawn | |
| STR375-940-000 | Withdrawn | |
| LINC9941 | Withdrawn | |
| SMI7206010 | Withdrawn | |
| SMI7205317 | Withdrawn | |
| LINC9911 | Withdrawn | |
| ARTAR-8380DS | Withdrawn | |
| LINC9290 | Withdrawn | |
| STR375-638-000 | Withdrawn | |
| SMI72203519 | Withdrawn | |
| STR375-628-000 | Withdrawn | |
| LIN9260A | Withdrawn | |
| STR375-941-012 | Withdrawn | |
| STR375-951-112 | Withdrawn | |
| STR275-637-000 | Withdrawn | |
| STR375-627-000 | Withdrawn | |
| STR375-941-000 | Withdrawn | |
| STR375-951-012 | Withdrawn | |
| LIN9599A | Withdrawn | |
| STR375-548-000 | Withdrawn | |
| SMI4225 | Withdrawn | |
| ARTAR-8550DS | Withdrawn | |
| SMI72203521 | Withdrawn | |
| ARTAR-8400DC | Withdrawn | |
| ARTAR-8400ST | Withdrawn | |
| STR375-951-100 | Withdrawn | |
| ARTAR-8500SR | Withdrawn | |
| ARTAR-8380BC | Withdrawn | |
| SMI3410 | Withdrawn | |
| LINC9760 | Withdrawn | |
| SMI7205307 | Withdrawn | |
| ARTAR-8400RBE | Withdrawn | |
| ARTAR-8550BC | Withdrawn | |
| LIN9399A | Withdrawn | |
| STR375-542-000 | Withdrawn | |
| STR275-627-000 | Withdrawn | |
| STR275-940-012 | Withdrawn | |
| SMI7209201 | Withdrawn | |
| STR375-555-000 | Withdrawn | |
| ARTAR-8500DS | Withdrawn | |
| STR275-544-000 | Withdrawn | |
| ARTAR-8550OBT | Withdrawn | |
| STR375-532-000 | Withdrawn | |
| STR375-450-500 | Withdrawn | |
| SMI7210499 | Withdrawn | |
| STR275-638-000 | Withdrawn | |
| STR375-534-000 | Withdrawn | |
| SMI72200081 | Withdrawn | |
| LINC9950 | Withdrawn | |
| LINC9112 | Withdrawn | |
| LINC9940 | Withdrawn | |
| SMI7210486 | Withdrawn | |
| ARTAR-8400EX | Withdrawn | |
| LINMC9248 | Withdrawn | |
| SMI72203013 | Withdrawn | |
| LIN9298A | Withdrawn | |
| SMI7205329 | Withdrawn | |
| LINH9101 | Withdrawn | |
| LINC9951 | Withdrawn | |
| LINC9405A | Withdrawn | |
| STR375-951-200 | Withdrawn | |
| SMI3419 | Withdrawn | |
| SMI7205305 | Withdrawn | |
| STR375-566-000 | Withdrawn | |
| SMI7205314 | Withdrawn | |
| LINH9112 | Withdrawn | |
| STR375-641-000 | Withdrawn | |
| SMI7206013 | 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 |
| Sustainable Technologies | Provision | 150 |
| Medline Renewal | Medline Industries, Inc. | 123 |
| Stryker | Provision | 113 |
| Arthrex® | Arthrex, Inc. | 109 |
| 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 |
|---|---|
| K012536 | 2001-11-02 |
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.