Zavation
ZVplasty System Assembly
21manufacturers in China registered for this device type
4catalogue numbers in this listing
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 | Zavation, United States |
|---|---|
| FDA product code | HRX |
| Device type | Arthroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K141419 |
| Record published | 2019-03-15 |
| Record revised | 2024-04-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VCF-1020-2-LV-XXC | In distribution | |
| VCF-1020-2-LV-E-XDX | In distribution | |
| VCF-1020-2-LV-XDC | In distribution | |
| VCF-1020-2-XDX | In distribution |
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® | Arthrex, Inc. | 109 |
| Arthrex | Provision | 109 |
| Eberle | Eberle GmbH & Co. KG | 92 |
Showing 12 of 567. All products under Arthroscope
Recalls Naming This Product
36 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 56 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 38 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 335 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 88 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 14 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 11 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 72 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 1 unit | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 98 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 113 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 15 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 72 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 162 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 34 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 98 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 27 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 11 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 113 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 15 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 22 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 |
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.