Fragment Fixation System
Fragment Fixation System: 77 catalogue numbers listed by Orthofix SRL, Italy, under Component, Traction, Invasive. 1 manufacturer in China is registered for this product code.
1manufacturer
77catalogue 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 | Orthofix SRL, Italy |
|---|---|
| FDA product code | JEC |
| Device type | Component, Traction, Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K944092 |
| Record published | 2015-09-01 |
| Record revised | 2025-10-24 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Length 110 to 120 mm; width 152 to 159 mm; outer diameter 1.2 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | Width 154 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 1.2 MM | In distribution |
| 1 | Width 158 mm | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | THREAD DIAMETER 1.2 MM | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | THREAD DIAMETER 1.2 MM | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | THREAD DIAMETER 1.2 MM | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | Outer Diameter 1.2 mm | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | THREAD LENGHT 30 MM | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 2.5 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | THREAD DIAMETER 1.2 MM | In distribution |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | In distribution | |
| 1 | THREAD LENGHT 30 MM | In distribution |
| 1 | Width 153 mm | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | THREAD DIAMETER 1.2 MM | In distribution |
| 1 | THREAD LENGTH 25 MM | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | THREAD DIAMETER 1.2 MM | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | THREAD DIAMETER 1.2 MM | In distribution |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | In distribution | |
| 1 | Width 156 mm | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | Width 155 mm | In distribution |
| 1 | THREAD DIAMETER 1.2 MM | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | THREAD LENGTH 50 MM | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | THREAD DIAMETER 1.2 MM | In distribution |
| 1 | Width 152 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | Width 159 mm | In distribution |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | THREAD DIAMETER 1.2 MM | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
| 1 | Outer Diameter 2.2 mm | In distribution |
| 1 | Width 157 mm | In distribution |
| 1 | THREAD DIAMETER 1.6 MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 115 |
| 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 |
| DigiFix | Virak Orthopedics LLC | 3 |
Showing 12 of 65. All products under Component, Traction, Invasive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K944092 | 1995-04-04 |
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.