De Mayo D2® Knee Positioner®
Loaner D2® Knee Positioner®(30" Baseplate w/Removable carriage, Push Button™ Clamp & Aluminum Boot)
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (4), Shanghai (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
| Kunshan Jiehong Nonwoven Product Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 12 |
| Fenglin Industry Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 10 |
| Hubei Yinkang Medical Equipment Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 8 |
| Donghai Xingchen NON-Woven Products Co., Ltd. | North Donghai Development Zone, Lianyungang | Jiangsu | Contract manufacturer | 7 |
| Jiangyin Puremed | Jiangyin | Jiangsu | Contract manufacturer | 7 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 37 |
Showing 12 of 25. All 25 manufacturers in China registered for Operating Room Accessories Table Tray
Record
| Listed by | Innovative Medical Products, Inc., United States |
|---|---|
| FDA product code | FWZ |
| Device type | Operating Room Accessories Table Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4950 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-07-19 |
| Record revised | 2025-02-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2024-06-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 803-114-S BP DEMO | In distribution | |
| 803-114-S-C713-7-P | In distribution | |
| 803-114-S-621-A713-7-P | In distribution | |
| 803-114-S-A713-3 | In distribution | |
| 803-114-S KIT | In distribution | |
| 803-114 KIT | In distribution | |
| 803-114-713 LOANER | In distribution | |
| 803-114-923S KIT-P | In distribution | |
| 803-114-A713-3 | In distribution | |
| 803-114-S BP | In distribution | |
| 803-114-S-A120 | In distribution | |
| 803-114-621 KIT | In distribution | |
| 803-114 DEMO | In distribution | |
| 803-114-S-621-A120-P | In distribution | |
| 803-114-S-923S-A713-7-P | In distribution | |
| 803-114-C713-7 | In distribution | |
| 803-114-621 KIT-P | In distribution | |
| 803-114-S-621 KIT | In distribution | |
| 803-114-120 Loaner | In distribution | |
| 803-114-S-713 LOANER | In distribution | |
| 803-114-S-717-LAB KIT | In distribution | |
| 803-114-923S-A713-7 | In distribution | |
| 803-114-907-A120 | In distribution | |
| 803-114-621-A713-7-PS | In distribution | |
| 803-114-S-621-A120 | In distribution | |
| 803-114-S Kit-P | In distribution | |
| 803-114-923-A713-7 | In distribution | |
| 803-114-S-120-LAB KIT | In distribution | |
| 803-114-713 DEMO | In distribution | |
| 803-114-S-907-A120 | In distribution | |
| 803-114-621-A120 | In distribution | |
| 803-114-S-907-A713-7 | In distribution | |
| 803-114 Loaner | In distribution | |
| 803-114-621-A713-7 | In distribution | |
| 803-114 ABD | In distribution | |
| 803-114-SHA LOANER | In distribution | |
| 803-114-713-LAB KIT | In distribution | |
| 803-114-BP DEMO | In distribution | |
| 803-114-923S-A713-7-P | In distribution | |
| 803-114-CN-6 | In distribution | |
| 803-114-621-A713-7-P | In distribution | |
| 803-114-S-621 KIT-P | In distribution | |
| 803-114-S LOANER | In distribution | |
| 803-114-717-LAB KIT | In distribution | |
| 803-114-S-120 Loaner | In distribution | |
| 803-114-S ABD | In distribution | |
| 803-114-S-A120-P | In distribution | |
| 803-114-923-A713-7-P | In distribution | |
| 803-114-907 Kit-P | In distribution | |
| 803-114-S-621-A713-7 | In distribution | |
| 803-114-923S KIT | In distribution | |
| 803-114-A713-7 | In distribution | |
| 803-114-NP | In distribution | |
| 803-114-120-LAB KIT | In distribution | |
| 803-114-A713-7-PS | In distribution | |
| 803-114-S-C713-7 | In distribution | |
| 803-114-A713-7-P | In distribution | |
| 803-114-621-A120-P | In distribution | |
| 803-114-S-923S-A713-7 | In distribution | |
| 803-114-S-907-A120-P | In distribution | |
| 803-114-S-A713-7-P | In distribution | |
| 803-114-BP | In distribution | |
| 803-114-SHA | In distribution | |
| 803-114-A120 | In distribution | |
| 803-114-717 LOANER | In distribution | |
| 803-114-A120-P | In distribution | |
| 803-114-S-A713-7 | In distribution | |
| 803-114-SNP | In distribution | |
| 803-114-S-717 LOANER | In distribution | |
| 803-114 KIT-P | In distribution | |
| 803-114-907-A713-7 | Withdrawn | |
| 803-114-907-ABD | Withdrawn | |
| 803-114-S-CBD KIT | Withdrawn | |
| 803-114-907-A713-7-P | Withdrawn | |
| 803-114-S-907-ABD | Withdrawn | |
| 803-114-907-A713-3 | Withdrawn | |
| 803-114-CBD KIT | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SchureMed | Schuerch Corporation | 1,115 |
| Allen | Hill-ROM, Inc. | 258 |
| Scanlan® Surg-I-Band® color coding | Scanlan International, Inc. | 166 |
| Operating Room Accessories Table Tray | MID Central Medical | 151 |
| Operating Room Accessories Table Tray | Smith & Nephew, Inc. | 97 |
| Schaerer Medical USA | Schaerer Medical USA Inc | 96 |
| TSI | Tedan Surgical Innovations, L.L.C. | 87 |
| MorphBoard® | Innovative Medical Products, Inc. | 73 |
| AXS | Axcess Surgical Innovations, LLC | 72 |
| Mayfield® | Integra Lifesciences Corporation | 69 |
| De Mayo Knee Positioner® | Innovative Medical Products, Inc. | 62 |
| De Mayo Adapt2Fit® Modular Knee Positioner | Innovative Medical Products, Inc. | 53 |
Showing 12 of 340. All products under Operating Room Accessories Table Tray
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.