General Instruments
Spica Table ARM BAR, Double Width
3manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Hebei (1), Sichuan (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang | Hebei | Manufacturer | 29 |
| Chengdu Ruinuo Meijer Medical Instrument Co., Ltd. | Chengdu | Sichuan | Manufacturer | 11 |
| Shanghai PAX Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | JEB |
| Device type | Table, Surgical With Orthopedic Accessories, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4950 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-31 |
| Record revised | 2025-07-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03-0904-0319 | In distribution | |
| 03-0904-0318 | In distribution | |
| 03-1006-0401 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spica Table | Orthopediatrics, Corp | 34 |
| Alliant Biotech | Medisurge, LLC | 19 |
| Schaerer Medical USA | Schaerer Medical USA Inc | 12 |
| Prone Perfect | Orthopediatrics, Corp | 11 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 10 |
| Table, Surgical With Orthopedic Accessories, Manual | Depuy Spine, Inc. | 9 |
| Teligen | Medos International Sàrl | 3 |
| X-Ray Top Head Section | Jörg & Sohn GmbH | 2 |
| X-Ray Top Seat Section TS7000 | Jörg & Sohn GmbH | 2 |
| the bump | General Hospital Supply Corp. | 2 |
| Emerson Knee Bump | Biomet Orthopedics | 2 |
| X-Ray Top Back Section TS7000 | Jörg & Sohn GmbH | 2 |
Showing 12 of 32. All products under Table, Surgical With Orthopedic Accessories, Manual
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.