Arthroscope
Full Radius Inner BoneCutter Straight Blade (Forest Green)
21manufacturers in China registered for this device type
61catalogue numbers in this listing
1recall
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 | Stryker Sustainability Solutions, 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) | K012635 |
| Record published | 2016-09-23 |
| Record revised | 2023-05-04 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6, pack of 5 |
| Sizes | Length 12.5 to 13.2 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N/A | Diameter: 3.5 Millimeter | In distribution |
| N/A | Length 12.5 cm | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 4.5 Millimeter | In distribution |
| N/A | Diameter: 4.0 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 5.0 Millimeter | In distribution |
| N/A | Diameter: 4.5 Millimeter | In distribution |
| N/A | Diameter: 4.0 Millimeter | In distribution |
| N/A | Diameter: 4.0 Millimeter | In distribution |
| N/A | Diameter: 3.5 Millimeter | In distribution |
| N/A | Diameter: 4.0 Millimeter | In distribution |
| N/A | Diameter: 4.0 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 4.5 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Length 13.2 cm | In distribution |
| N/A | Diameter: 4.0 Millimeter | In distribution |
| N/A | Diameter: 3.5 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 4.5 Millimeter | In distribution |
| N/A | Diameter: 4.5 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 5.0 Millimeter | In distribution |
| N/A | Diameter: 4.5 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 4.5 Millimeter | In distribution |
| N/A | Diameter: 4.0 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 5.0 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Length 12.5 cm | In distribution |
| N/A | Diameter: 4.5 Millimeter | In distribution |
| N/A | Diameter: 3.5 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Length 12.5 cm | In distribution |
| N/A | Diameter: 4.0 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 4.5 Millimeter | In distribution |
| N/A | Diameter: 4.0 Millimeter | In distribution |
| N/A | Diameter: 4.5 Millimeter | In distribution |
| N/A | Diameter: 5.0 Millimeter | In distribution |
| N/A | Length 12.5 cm | In distribution |
| N/A | Length 12.5 cm | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 3.5 Millimeter | In distribution |
| N/A | Diameter: 4.5 Millimeter | In distribution |
| N/A | Diameter: 5.0 Millimeter | In distribution |
| N/A | Diameter: 3.5 Millimeter | In distribution |
| N/A | Diameter: 5.5 Millimeter | In distribution |
| N/A | Diameter: 4.0 Millimeter | In distribution |
| N/A | Diameter: 4.5 Millimeter | In distribution |
| N/A | Diameter: 4.0 Millimeter | In distribution |
| N/A | Diameter: 4.5 Millimeter | In distribution |
| N/A | Length 13.2 cm | In distribution |
| N/A | Diameter: 3.5 Millimeter | In distribution |
| N/A | Diameter: 4.0 Millimeter | 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
16 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 |
|---|---|---|---|---|---|---|---|
| Stryker Sustainability Solutions | 510(k) number | 2018-07-27 | Class II | Software Design Change | Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 | 14,265 units | 2020-09-17 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 330 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 18 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 30 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 24 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 36 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 102 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 168 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 25 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 70 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 400 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 1575 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 200 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 440 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 220 devices | 2012-03-09 |
| Stryker Sustainability Solutions Phoenix | 510(k) number | 2009-01-26 | Not classified | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential bre | 40 devices | 2012-03-09 |
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.