Triax
Tube to Tube Clamp Yellow,Yellow
1manufacturer
26catalogue numbers in this listing
1510(k) clearance
1recall
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | JEC |
| Device type | Component, Traction, Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K936124 |
| Record published | 2016-09-24 |
| Record revised | 2026-06-24 (version 7) |
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 |
| Sizes | Length 150 to 400 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5150-4-070 | Diameter: 20.0 Millimeter | In distribution |
| 5150-2-471 | Diameter: 25.0 Millimeter | In distribution |
| 5150-3-165 | Diameter: 15.0 Millimeter | In distribution |
| 5150-2-431 | Length 200.0 mm | In distribution |
| 5150-2-381 | Length 200.0 mm | In distribution |
| 5150-2-411 | Length 300.0 mm | In distribution |
| 5150-2-461 | Diameter: 25.0 Millimeter | In distribution |
| 5150-3-435 | In distribution | |
| 5150-2-625 | Diameter: 25.0 Millimeter | In distribution |
| 5150-2-391 | Diameter: 15.0 Millimeter | In distribution |
| 5150-2-615 | Diameter: 15.0 Millimeter | In distribution |
| 5150-3-420 | In distribution | |
| 5150-2-451 | Diameter: 25.0 Millimeter | In distribution |
| 5150-3-445 | In distribution | |
| 5150-3-175 | Diameter: 25.0 Millimeter | In distribution |
| 5150-2-396 | Diameter: 15.0 Millimeter | In distribution |
| 5150-4-065 | Diameter: 15.0 Millimeter | In distribution |
| 5150-4-075 | Diameter: 25.0 Millimeter | In distribution |
| 5150-3-415 | In distribution | |
| 5150-3-170 | Diameter: 20.0 Millimeter | In distribution |
| 5150-2-421 | Diameter: 20.0 Millimeter | In distribution |
| 5150-2-620 | Diameter: 20.0 Millimeter | In distribution |
| 5150-2-481 | Diameter: 25.0 Millimeter | In distribution |
| 5150-3-425 | In distribution | |
| 5150-2-371 | Diameter: 15.0 Millimeter | In distribution |
| 5150-2-401 | Diameter: 20.0 Millimeter | 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 |
| 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 |
|---|---|
| K102885 | 2011-01-14 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2019-11-21 | Class II | Under Investigation by firm | Pin To Rod Coupling could not clamp the pin and rod as intended | 2020-11-13 |
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.