FusionMAX
FlexFrame- Patient supoort device. Designed to support and position torso in prone position. Two carbon fiber arc plates with removable pads fit into base that is attached to surgical table…
FlexFrame- Patient supoort device. Designed to support and position torso in prone position. Two carbon fiber arc plates with removable pads fit into base that is attached to surgical table top. Height adjustable with crank handle.
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Kanghui Medical Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 11 |
| Baxter Medical Systems (Suzhou) Co., Ltd. | Taicang | Jiangsu | Contract manufacturer | 4 |
| Nanjing Mindray BIO-Medical Electronics Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Surgix Medical LLC, United States |
|---|---|
| FDA product code | JEA |
| Device type | Table, Surgical With Orthopedic Accessories, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4960 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-09-10 |
| Record revised | 2023-10-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Sizes | Length 35 in; width 19 in; height 2 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 33501-12-000 | In distribution | |
| 33501-18-001 | In distribution | |
| 33501-26-001 | In distribution | |
| 33501-32-000 | In distribution | |
| 30427 | In distribution | |
| 33501-18-000 | In distribution | |
| 33516 | In distribution | |
| 33501-29-000 | In distribution | |
| 33577-01-000 | In distribution | |
| 33501-17-000 | In distribution | |
| 33501-21-002 | In distribution | |
| FM-10026 | In distribution | |
| FM-10027 | In distribution | |
| 33501-20-000 | In distribution | |
| 33501-21-003 | In distribution | |
| 33501-23-002 | Length 35 in | In distribution |
| 33501-23-000 | In distribution | |
| 33501-20-002 | In distribution | |
| FM-10041 | In distribution | |
| FM-HS | In distribution | |
| 33577-04-000 | In distribution | |
| 33501-16-000 | In distribution | |
| 33501-33-000 | In distribution | |
| 33501-11-000 | In distribution | |
| FM-10033 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hillrom™ | Baxter Medical Systems GmbH + Co. KG | 129 |
| Trumpf Medical | Baxter Medical Systems GmbH + Co. KG | 44 |
| Pads | Baxter Medical Systems GmbH + Co. KG | 41 |
| Orthopedic Extension | Baxter Medical Systems GmbH + Co. KG | 21 |
| TS 7500 | Baxter Medical Systems GmbH + Co. KG | 16 |
| Patient Support & Fixation | Baxter Medical Systems GmbH + Co. KG | 13 |
| IR remote control | Maquet Gmbh | 12 |
| Steris | Steris Corporation | 10 |
| DA Power Hook | United Orthopedic Corp. | 10 |
| Leg Sections | Baxter Medical Systems GmbH + Co. KG | 8 |
| Head-Positioning accessories | Baxter Medical Systems GmbH + Co. KG | 7 |
| Control Units | Baxter Medical Systems GmbH + Co. KG | 7 |
Showing 12 of 610. All products under Table, Surgical With Orthopedic Accessories, Ac-Powered
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.