Atec A.R.M.
Pneumatic Actuation and Regulation System
1manufacturer
8catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Sintang Health&Technology Co., Ltd. | Yancheng | Jiangsu | Manufacturer | 21 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | FWW |
| Device type | Table, Operating-Room, Pneumatic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4960 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-12-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 202-150 | In distribution | |
| 202-210-03 | In distribution | |
| 202-110-01 | In distribution | |
| 202-110-03 | In distribution | |
| 202-210-02 | In distribution | |
| 102-110-02 | In distribution | |
| 102-900 | In distribution | |
| 202-110-02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amsco | Steris Corporation | 1 |
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.