Steris
The STERIS OT 1050 Series Orthopedic Surgical Table without drive package performs a variety of orthopedic procedures, including anterior hips, maximizing operational efficiency while…
The STERIS OT 1050 Series Orthopedic Surgical Table without drive package performs a variety of orthopedic procedures, including anterior hips, maximizing operational efficiency while maintaining patient and staff safety.
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 | Steris Corporation, 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 | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-03-31 |
| Record revised | 2026-07-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2026-07-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OT 1050 Orthopedic Table | In distribution | |
| OT 1100 Orthopedic Table | In distribution | |
| OT 1100 Orthopedic Table | Withdrawn | |
| OT 1200 Orthopedic Table | Withdrawn | |
| OT 1100 Orthopedic Table | Withdrawn | |
| OT 1200 Orthopedic Table | Withdrawn | |
| OT 1100 Orthopedic Table | Withdrawn | |
| OT 1200 Orthopedic Table | Withdrawn | |
| OT 1100 Orthopedic Table | Withdrawn | |
| OT 1100 Orthopedic Table | Withdrawn |
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 |
| FusionMAX | Surgix Medical LLC | 25 |
| 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 |
| 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
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-01-21 | Class II | Process control | On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the affected leg spar if the separation occurred during a pat | 272 tables total (Domestic: 227 tables, Foreign 45 tables) | 2021-11-10 |
| 2016-05-23 | Class II | Other | STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly. | 148 | 2016-08-22 |
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.