DigiFix Sterile Kit
The DigiFix Sterile Kit is an external fixation system for finger treatment in skeletally mature patients. Its brackets, locking pins, set screws and K-wires form a frame that captures and…
The DigiFix Sterile Kit is an external fixation system for finger treatment in skeletally mature patients. Its brackets, locking pins, set screws and K-wires form a frame that captures and supports wires along the medial and lateral sides of the finger.
The frame components are assembled during surgery. Dynamic use includes selected interphalangeal fracture-dislocations and contractures, while static use includes phalangeal fractures and interphalangeal joint fusion. The selected configuration determines the treatment mode.
Listed Item
Single use DigiFix Sterile Kit
Kit Supply
The external fixator components are supplied sterile for single use. Dynamic indications include post-traumatic proximal interphalangeal joint contracture and Dupuytren’s contracture, as well as the specified unstable joint injuries.
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Virak Orthopedics LLC, United States |
|---|---|
| FDA product code | JEC |
| Device type | Component, Traction, Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K192465 |
| Record published | 2023-08-15 |
| Record revised | 2024-02-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1146-STKT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 115 |
| Fragment Fixation System | Orthofix SRL | 77 |
| Anjon Bremer Halo System | Anjon Holdings, LLC | 68 |
| Sheffield Ring Fixator | Orthofix SRL | 68 |
| Hoffmann | Stryker GmbH | 65 |
| Hybrid Fixator System | Orthofix SRL | 30 |
| Triax | Stryker GmbH | 26 |
| Bremer | Depuy Spine, Inc. | 11 |
| Additional Accessories FOR THE Orthofix System | Orthofix SRL | 10 |
| Component, Traction, Invasive | Synthes Gmbh | 9 |
| Distraction, Internal | KLS-Martin L.P. | 9 |
| Halo Systems | Ossur Americas | 4 |
Showing 12 of 65. All products under Component, Traction, Invasive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192465 | 2019-10-10 |
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.