DigiFix
Bracket Assembly - 1146-3000
1manufacturer
3catalogue numbers in this listing
1510(k) clearance
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) | K132731 |
| Record published | 2017-06-02 |
| Record revised | 2024-02-19 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1146-0007 | In distribution | |
| 1146-0001 | In distribution | |
| 1146-0006 | 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.