OsteoBridge™ Idsf Diaphysis Tibial Nail
4 catalogue numbers from 10 90, listed by Merete Gmbh, Germany, under Instrument, Clip Forming/Cutting. 1 manufacturer in China is registered for this product code.
1manufacturer
4catalogue numbers in this listing
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 | Merete Gmbh, Germany |
|---|---|
| FDA product code | HBS |
| Device type | Instrument, Clip Forming/Cutting |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4190 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K181026 |
| Record published | 2018-10-31 |
| Record revised | 2025-06-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 9 to 10 mm; length 60 to 130 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10 90 | Outer Diameter 10 mm | In distribution |
| 9 70 | Outer Diameter 9 mm | In distribution |
| 10 130 | Outer Diameter 10 mm | In distribution |
| 9 60 | Outer Diameter 9 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acumed | Acumed LLC | 8 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 3 |
| Expert Tibia Nail | Auxein medical Private limited | 1 |
| 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.