GEO Bone Screw System
K-Wire Pack (2) 1.2mmx100mm for 3mm Bone Screw
2manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Gramercy Extremity Orthopedics, LLC., United States |
|---|---|
| FDA product code | LRN |
| Device type | Wire, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K161904 |
| Record published | 2018-10-10 |
| Record revised | 2024-02-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 55 °C |
| Sizes | Outer diameter 0.9 to 2.5 mm; length 100 to 230 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13216150 | Length 150 mm | In distribution |
| 13009100 | Outer Diameter 0.9 mm | In distribution |
| 13012100 | Outer Diameter 1.2 mm | In distribution |
| 13025150 | Length 150 mm | In distribution |
| 13016100 | Length 100 mm | In distribution |
| 13225150 | Outer Diameter 2.5 mm | In distribution |
| 13025230 | Length 230 mm | In distribution |
| 13109100 | Length 100 mm | In distribution |
| 71130002 | Outer Diameter 1.2 mm | In distribution |
| 13225230 | Length 230 mm | In distribution |
| 13216100 | Length 100 mm | In distribution |
| 13016150 | Outer Diameter 1.6 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wire, Surgical | Synthes Gmbh | 22 |
| Atlas® Cable System | Medtronic Sofamor Danek, Inc. | 11 |
| Dall-Miles | Howmedica Osteonics Corp | 7 |
| LapiLock | Fusion Orthopedics, LLC | 6 |
| FibFix | Fusion Orthopedics, LLC | 5 |
| FuzeFix Max FT | Fusion Orthopedics, LLC | 3 |
| K-Wire with stop 1.0mm | Biopro, Inc. | 2 |
| Wire, Surgical | Depuy Intl., Ltd. | 1 |
| Control | Depuy Orthopaedics, Inc. | 1 |
| FuzeRight | Fusion Orthopedics, LLC | 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.