Alexis ® Orthopaedic Protector
Flexible Alexis Orthopaedic Protector
3manufacturers in China registered for this device type
8catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. | Siyang | Jiangsu | Manufacturer | 21 |
| Jiangsu Haize Medical Scientific Development Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 9 |
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
Record
| Listed by | Applied Medical Resources Corp., United States |
|---|---|
| FDA product code | KGW |
| Device type | Ring (Wound Protector), Drape Retention, Internal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2025-09-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HR004 | 2.5-8cm Incision Size | In distribution |
| HR104 | 2.5-8 cm | In distribution |
| HR101 | 2.5-8 cm | In distribution |
| HR005 | Incision Size 5-13cm | In distribution |
| HR001 | Incision Size 2.5-8 cm | In distribution |
| HR105 | 5-13 cm | In distribution |
| HR100 | Incision Size 2.5-7 cm | In distribution |
| HR000 | Incision Size 2.5-7 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alexis Wound Protector-Retractor | Applied Medical Resources Corp. | 8 |
| Alexis O Wound Protector-Retractor | Applied Medical Resources Corp. | 6 |
| EZ Access™ | V L V Associates (inc) | 5 |
| Convertors | Cardinal Health 200, LLC | 3 |
| Alexis Laparoscopic System | Applied Medical Resources Corp. | 2 |
| Alexis® Lighted Wound Protector-Retractor | Applied Medical Resources Corp. | 2 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260982 | 2026-04-24 |
| K253531 | 2026-02-23 |
| K113268 | 2013-02-08 |
| K100120 | 2010-04-02 |
| K093296 | 2009-11-05 |
| K062907 | 2007-01-09 |
| K041711 | 2004-08-26 |
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.