Osseointegration Prosthetic Limb
5 mm Hex Distal Locking Screw - M10 Includes O-ring
6manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Fujian (2), Guangdong (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Baoji Shengtaike Industry & Trade Co., Ltd. | Baoji | Shanxi | Contract manufacturer | 7 |
| Orthotech Rehabilitation Co., Ltd. | Xiamen | Fujian | Manufacturer | 26 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Huae Trade Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 10 |
| T&L (Jiaxing) Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 4 |
| Fujian Guozi Rehabilitation Medical Co., Ltd. | Fuzhou | Fujian | Manufacturer | 2 |
Record
| Listed by | Osseointegration International Pty Ltd, Australia |
|---|---|
| FDA product code | IQO |
| Device type | Device, Prosthesis Alignment |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3025 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-16 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M10 Grub Screw Left Connector | In distribution | |
| M10 Grub Screw Right Connector | In distribution | |
| M10 Screw | In distribution | |
| M14 Screw | In distribution | |
| 8 mm Hex Clamp Screw | In distribution | |
| M10 Grub Screw Tibial Connector | In distribution | |
| 0 Degree Bushing | In distribution | |
| 5 mm Hex Grub Screw – M10 | In distribution | |
| M10 Screw | In distribution | |
| 8 Rotational Offset Taper Sleeve | In distribution | |
| O-Ring | In distribution | |
| 8 mm Hex Clamp Screw | In distribution | |
| M14 Screw | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoskeletal Components | College Park Industries | 102 |
| Juzo SoftCompress | Julius Zorn, Inc. | 19 |
| C100 Cylindrical Shuttle Lock | College Park Industries | 13 |
| Juzo Night | Julius Zorn, Inc. | 12 |
| Torsion Adapter | College Park Industries | 6 |
| LA Liner, Pin, Tapered, 9mm, Medium | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Uniform, 6mm, Large | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Uniform, 3mm, Medium+ | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Uniform, 9mm, Medium | Silipos Holding LLC | 2 |
| LA Liner, Pin, Uniform, 3mm, Large+ | Silipos Holding LLC | 2 |
| LA Liner, Pin, Tapered, 3mm, Medium+ | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Tapered, 3mm, Medium+ | Silipos Holding LLC | 2 |
Showing 12 of 38. All products under Device, Prosthesis Alignment
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.