OrthoSolutions ‘System26’ Bone Screws
Countersink FOR 6.5MM Headless Screw Cannulated Jacobs QC
5manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
| Changzhou Centrau Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Ortho Solutions Inc, United States |
|---|---|
| FDA product code | HWW |
| Device type | Countersink |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Complaint-file establishment |
| 510(k) | K163489 |
| Record published | 2018-08-30 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OS900082-NS | In distribution | |
| OS900050-NS | In distribution | |
| OS900081-NS | In distribution | |
| OS900043-NS | In distribution | |
| OS900044-NS | In distribution | |
| OS900049-NS | In distribution | |
| OS900048-NS | In distribution | |
| OS900051-NS | In distribution | |
| OS900045-NS | In distribution | |
| OS900046-NS | In distribution | |
| OS900047-NS | In distribution | |
| OS900042-NS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vilex Tool | Vilex IN Tennessee, Inc. | 25 |
| Countersink | Synthes Gmbh | 21 |
| Countersink | AAP Implantate AG | 18 |
| Countersink | Merete Gmbh | 16 |
| Medline | Medline Industries, Inc. | 12 |
| Healix | Nvision Biomedical Technologies, Inc | 10 |
| Leos Cannulated Screw System | Tyber Medical | 10 |
| Cardinal Health | Cardinal Health 200, LLC | 10 |
| Tiger | Trilliant Surgical LLC | 9 |
| Dart-Fire | Wright Medical Technology, Inc. | 9 |
| GEO Bone Screw System | Gramercy Extremity Orthopedics, LLC. | 9 |
| Tools – HCS | Trimed, Inc. | 8 |
Showing 12 of 123. All products under Countersink
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.