Healix
2.0 Headless Countersink. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for,…
2.0 Headless Countersink. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
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 | Nvision Biomedical Technologies, Inc, United States |
|---|---|
| FDA product code | HWW |
| Device type | Countersink |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2019-09-30 |
| Record revised | 2026-07-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CSRW-1000T-245 | In distribution | |
| CSRW-1000T-226 | In distribution | |
| CSRW-1000T-241 | In distribution | |
| CSRW-1000T-243 | In distribution | |
| CSRW-1000T-240 | In distribution | |
| CSRW-1000T-244 | In distribution | |
| CSRW-1000T-242 | In distribution | |
| CSRW-1000T-228 | In distribution | |
| CSRW-1000T-229 | In distribution | |
| CSRW-1000T-227 | 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 |
| 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.