Mountaineer
MOUNTAINEER OCT SPINAL SYSTEM MONOAXIAL EXTENDED TAB SCREW 3.5 x 3.5 x 36mm
11manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K042508 |
| Record published | 2015-09-24 |
| Record revised | 2025-12-08 (version 9) |
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 |
| Distribution end date | 2025-11-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 188362012 | In distribution | |
| 188363200 | In distribution | |
| 188321340 | In distribution | |
| 188362109 | In distribution | |
| 188362027 | In distribution | |
| 188365000 | In distribution | |
| 188362116 | In distribution | |
| 188341200 | In distribution | |
| 188321326 | In distribution | |
| 188362037 | In distribution | |
| 188362110 | In distribution | |
| 188321338 | In distribution | |
| 188362113 | In distribution | |
| 188362107 | In distribution | |
| 188363100 | In distribution | |
| 188362016 | In distribution | |
| 188343001 | Withdrawn | |
| 188343002 | Withdrawn | |
| 188343003 | Withdrawn | |
| 188321334 | Withdrawn | |
| 188341042 | Withdrawn | |
| 188322336 | Withdrawn | |
| 188328318 | Withdrawn | |
| 188341049 | Withdrawn | |
| 188322334 | Withdrawn | |
| 188322326 | Withdrawn | |
| 188343000 | Withdrawn | |
| 188328320 | Withdrawn | |
| 188341300 | Withdrawn | |
| 188341100 | Withdrawn | |
| 188341028 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
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.