Countersink
Countersink FOR 3.5 Cortex AND 4.0 Cancellous Screws/Yellow
5manufacturers in China registered for this device type
21catalogue 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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HWW |
| Device type | Countersink |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-12-31 |
| Record revised | 2025-11-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 310.79 | In distribution | |
| 310.85 | In distribution | |
| 03.530.010 | In distribution | |
| 310.99 | In distribution | |
| 310.89 | In distribution | |
| 310.804 | In distribution | |
| 310.803 | In distribution | |
| 03.130.260 | In distribution | |
| 03.119.026 | In distribution | |
| 03.045.034 | In distribution | |
| 310.972 | In distribution | |
| 310.88 | In distribution | |
| 310.86 | In distribution | |
| 310.78 | In distribution | |
| 310.971 | In distribution | |
| 310.87 | In distribution | |
| 310.96 | In distribution | |
| 03.119.004 | In distribution | |
| 03.119.022 | In distribution | |
| 03.119.017 | In distribution | |
| 03.045.034S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vilex Tool | Vilex IN Tennessee, Inc. | 25 |
| Countersink | AAP Implantate AG | 18 |
| Countersink | Merete Gmbh | 16 |
| Medline | Medline Industries, Inc. | 12 |
| OrthoSolutions ‘System26’ Bone Screws | Ortho Solutions 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.