Arsenal Deformity Spinal Fixation System
ILIAC BOLT, 30 DEGREE, 10.5mm X 65mm
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | NMH |
| Device type | Laparoscope And Accessories, Gynecologic, Reprocessed |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K152968 |
| Record published | 2016-04-27 |
| Record revised | 2024-09-11 (version 6) |
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 |
| Sizes | Angle 30 °; outer diameter 10.5 mm; length 65 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48700-030-105-065 | Angle 30 ° | In distribution |
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.