Expert Tibia Nail
Ø4.4mm Locking Bolt, Self Tapping, Length 62mm, Titanium
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Auxein medical Private limited, India |
|---|---|
| FDA product code | HBS |
| Device type | Instrument, Clip Forming/Cutting |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4190 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K192003 |
| Record published | 2020-10-21 |
| Record revised | 2025-02-06 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TI-520-058-62 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acumed | Acumed LLC | 8 |
| OsteoBridge™ Idsf Diaphysis Tibial Nail | Merete Gmbh | 4 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 3 |
| Henry Schein | Henry Schein, Inc. | 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.