Kmedic
Countersink 4 3/4" 3.2 Millimeter Malleolar
5manufacturers in China registered for this device type
1catalogue number
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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | HWW |
| Device type | Countersink |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2019-12-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 11.4 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN014334 | Length 11.4 cm | 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 |
| 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 |
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.