LapiLock
Sagittal Saw, 40 mm
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guizhou (1), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guizhou Zirui Technology Co., Ltd. | Tongzi County, Zunyi | Guizhou | Manufacturer | 4 |
| Wuhu Ruijin Medical Instrument & Device Co., Ltd. | Wuhu | Anhui | Manufacturer | 1 |
Record
| Listed by | Fusion Orthopedics, LLC, United States |
|---|---|
| FDA product code | DWI |
| Device type | Saw, Electrically Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Record published | 2023-07-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CD-LL-1540-S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oscillating Microsaw G2 | Bien-AIR Surgery SA | 1 |
| Osseoscalpel Microsaw G2 | Bien-AIR Surgery SA | 1 |
| Compass Microsaw G2 | Bien-AIR Surgery SA | 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.