Mountaineer
MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 25mm
4manufacturers in China registered for this device type
213catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| 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 | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| 510(k) | K110353 |
| 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 |
|---|---|---|
| 188320420 | In distribution | |
| 188311301 | In distribution | |
| 188311203 | In distribution | |
| 188311201 | In distribution | |
| 188311202 | In distribution | |
| 188311303 | In distribution | |
| 188311103 | In distribution | |
| 188311002 | In distribution | |
| 188310022 | In distribution | |
| 188319324 | In distribution | |
| 188311022 | In distribution | |
| 188320424 | In distribution | |
| 188318550 | In distribution | |
| 188318318 | In distribution | |
| 188311230 | In distribution | |
| 188320422 | In distribution | |
| 188310011 | In distribution | |
| 188311130 | In distribution | |
| 188311102 | In distribution | |
| 188311302 | In distribution | |
| 188320446 | In distribution | |
| 188311200 | In distribution | |
| 188318545 | In distribution | |
| 188311204 | In distribution | |
| 188310065 | Withdrawn | |
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| 188319350 | Withdrawn | |
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| 188318448 | Withdrawn | |
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| 188320336 | Withdrawn | |
| 188310040 | Withdrawn | |
| 188318535 | Withdrawn | |
| 188319344 | Withdrawn | |
| 188311100 | Withdrawn | |
| 188318540 | Withdrawn | |
| 188316040 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bridalveil | Astura Medical | 1,718 |
| Proficient™ Posterior Cervical Spine System | Spine Wave, Inc. | 1,590 |
| Invictus | Alphatec Spine, Inc. | 1,538 |
| Paeon Posterior Cervical Fixation System | Aegis Spine | 1,408 |
| ReLine | Nuvasive, Inc. | 1,072 |
| PathLoc-C Posterior Cervical Fixation System | L&K Biomed Co., Ltd. | 706 |
| Cosy | Signus Medizintechnik Gmbh | 550 |
| Yukon OCT Spinal System | VB Spine LLC | 451 |
| Astra-OCT Spine System | Spinecraft LLC | 440 |
| Symphony | Medos International Sàrl | 389 |
| Medyssey Poseidon OCT Spinal Fixation System | Medyssey Co., Ltd. | 387 |
| Infinity™ Occipitocervical Upper Thoracic System | Medtronic Sofamor Danek, Inc. | 375 |
Showing 12 of 336. All products under Posterior Cervical Screw System
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.