Malibu
Sublaminar Wire, Sterilization Tube
3manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | HXS |
| Device type | Twister, Wire |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-05-02 |
| Record revised | 2025-10-24 (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 |
|---|---|---|
| 91-2585 | DIA.045 x 18″ | In distribution |
| 91-5901 | 11in | In distribution |
| 91-2581 | DIA.045 x 4″ | In distribution |
| 91-2584 | DIA.045 x 12″ | In distribution |
| 91-2582 | DIA.045 x 5″ | In distribution |
| 91-2583 | DIA.045 x 9″ | In distribution |
| 91-2540 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| gSource | Gsource, LLC. | 22 |
| Forceps | KLS-Martin L.P. | 13 |
| Twister, Wire | Biomet Microfixation | 12 |
| Orthomed | Ortho-MED, Inc. | 12 |
| NewPort | Seaspine Orthopedics Corporation | 12 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 11 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 10 |
| Ambler Surgical | Ambler Surgical, LLC | 10 |
| Sklar® | Sklar Corporation | 9 |
| Millennium | Avalign Technologies, Inc. | 8 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 7 |
| Kmedic | Teleflex Medical LLC | 7 |
Showing 12 of 57. All products under Twister, Wire
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.