Axle Interspinous Fusion System
MODULAR TIP, LOCKING PLATE, 36mm; ALL-IN-ONE PARALLEL INSERTER, AXLE X SYSTEM
8manufacturers in China registered for this device type
35catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (3), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| 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 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Qingdao Taniking Garment Co., Ltd. | Qingdao | Shandong | Manufacturer | 2 |
Record
| Listed by | Xtant Medical Holdings, Inc., United States |
|---|---|
| FDA product code | HWN |
| Device type | Instrument, Compression |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2015-05-26 |
| Record revised | 2021-06-03 (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 |
| Sizes | Length 28 to 291 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X060-6039L | Length 39 mm | In distribution |
| X060-0385 | In distribution | |
| X060-0310 | In distribution | |
| X060-6036LX | Length 36 mm | In distribution |
| X060-6055L | Length 55 mm | In distribution |
| X060-6038L | Length 38 mm | In distribution |
| X060-6030L | Length 30 mm | In distribution |
| X060-6029LX | Length 29 mm | In distribution |
| X060-6032L | Length 32 mm | In distribution |
| X060-0370 | In distribution | |
| X060-6045L | Length 45 mm | In distribution |
| X060-6034LX | Length 34 mm | In distribution |
| X060-6039LX | Length 39 mm | In distribution |
| X060-6028L | Length 28 mm | In distribution |
| X060-6033LX | Length 33 mm | In distribution |
| X060-6050L | Length 50 mm | In distribution |
| X060-6036L | Length 36 mm | In distribution |
| X060-6000 | In distribution | |
| X060-6038LX | Length 38 mm | In distribution |
| X060-6028C | Length 28 mm | In distribution |
| X060-0314 | In distribution | |
| X060-6037LX | Length 37 mm | In distribution |
| X060-6040L | Length 40 mm | In distribution |
| X060-6031L | Length 31 mm | In distribution |
| X060-6035L | Length 35 mm | In distribution |
| X060-6030LX | Length 30 mm | In distribution |
| X060-6032LX | Length 32 mm | In distribution |
| X060-6037L | Length 37 mm | In distribution |
| X060-6028LX | Length 28 mm | In distribution |
| X060-6033L | Length 33 mm | In distribution |
| X060-6040LX | Length 40 mm | In distribution |
| X060-6029L | Length 291 mm | In distribution |
| X060-6031LX | Length 31 mm | In distribution |
| X060-6034L | Length 34 mm | In distribution |
| X060-6035LX | Length 35 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument, Compression | Synthes Gmbh | 78 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 42 |
| Invictus | Alphatec Spine, Inc. | 37 |
| TrabecuLink Femoral and Tibial Cone – Instruments | Waldemar Link GmbH & Co. KG | 32 |
| Made-To-Order | Tornier Inc. | 28 |
| Instrument, Compression | Medtronic Sofamor Danek, Inc. | 20 |
| Tornier Flex | Tornier Inc. | 16 |
| General Instruments | Alphatec Spine, Inc. | 16 |
| Alpine XC Adjustable Fusion System | Highridge Medical, LLC | 14 |
| Coral | Seaspine Orthopedics Corporation | 12 |
| CosmoLock Pedicle Screw System | Kalitec Direct, LLC | 9 |
| Apelo® / Apelo® MIS | Atlas Spine Inc. | 9 |
Showing 12 of 196. All products under Instrument, Compression
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.