PathLoc-C Posterior Cervical Fixation System
PathLoc-C is a posterior cervical and upper-thoracic fixation family with screws, rods and set screws. The components join to immobilize spinal segments as an adjunct to fusion. The…
PathLoc-C is a posterior cervical and upper-thoracic fixation family with screws, rods and set screws. The components join to immobilize spinal segments as an adjunct to fusion.
The titanium alloy construct has a top-loading screw-and-rod arrangement. Straight and curved rods link the screw anchors, and set screws secure those rod connections.
Listed Item
PathLoc-C Cervical MIS Screw(Close Type, Sleeve 100mm) 4.0x24mm 1EA
Construct Scope
The system covers cervical levels C1 through C7 and upper-thoracic levels T1 through T3. Its components provide different rod shapes and fixation points within that region; an individual cervical screw is one anchor within the assembled construct.
4manufacturers in China registered for this device type
706catalogue numbers in this listing
4510(k) clearances naming this product code
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 | L&K Biomed Co., Ltd., South Korea |
|---|---|
| FDA product code | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K153439 |
| Record published | 2016-07-27 |
| Record revised | 2025-07-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6316-4012 | In distribution | |
| 6338-4012 | In distribution | |
| 6322-3514 | In distribution | |
| 6316-3530 | In distribution | |
| 6336-3514 | In distribution | |
| 6322-3570 | In distribution | |
| 6312-4026 | In distribution | |
| 6310-4026 | In distribution | |
| 6317-4042 | In distribution | |
| 6336-4024 | In distribution | |
| 6311-3536 | In distribution | |
| 6319-4018 | In distribution | |
| 6318-3532 | In distribution | |
| 6336-4046 | In distribution | |
| 6339-3514 | In distribution | |
| 6330-4024 | In distribution | |
| 6317-3534 | In distribution | |
| 6314-3532 | In distribution | |
| 6335-4048 | In distribution | |
| 6338-3516 | In distribution | |
| 6330-3526 | In distribution | |
| 6330-4046 | In distribution | |
| 6310-4010 | In distribution | |
| 6339-3526 | In distribution | |
| 6312-3524 | In distribution | |
| 6338-3514 | In distribution | |
| 6316-3544 | In distribution | |
| 6317-3542 | In distribution | |
| 6337-3514 | In distribution | |
| 6103-7037 | In distribution | |
| 6322-3510 | In distribution | |
| 6313-4046 | In distribution | |
| 6311-4028 | In distribution | |
| 6330-4042 | In distribution | |
| 6312-4036 | In distribution | |
| 6336-4020 | In distribution | |
| 6312-4014 | In distribution | |
| 6318-4024 | In distribution | |
| 6312-4010 | In distribution | |
| 6337-4038 | In distribution | |
| 6313-3534 | In distribution | |
| 6319-4022 | In distribution | |
| 6330-3528 | In distribution | |
| 6312-4040 | In distribution | |
| 6319-3528 | In distribution | |
| 6317-4016 | In distribution | |
| 6337-3542 | In distribution | |
| 6312-3510 | In distribution | |
| 6316-3534 | In distribution | |
| 6317-3538 | In distribution | |
| 6317-3536 | In distribution | |
| 6315-3546 | In distribution | |
| 6313-4050 | In distribution | |
| 6319-3526 | In distribution | |
| 6322-3512 | In distribution | |
| 6311-3532 | In distribution | |
| 6312-3528 | In distribution | |
| 6318-4022 | In distribution | |
| 6330-4012 | In distribution | |
| 6336-3510 | In distribution | |
| 6338-3532 | In distribution | |
| 6336-3536 | In distribution | |
| 6337-4044 | In distribution | |
| 6322-3580 | In distribution | |
| 6313-3524 | In distribution | |
| 6311-3518 | In distribution | |
| 6335-4022 | In distribution | |
| 6311-3546 | In distribution | |
| 6313-3532 | In distribution | |
| 6313-4034 | In distribution | |
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| 6318-4048 | In distribution | |
| 6319-3534 | In distribution | |
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| 6322-3513 | In distribution | |
| 6314-3518 | In distribution | |
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| 6337-4046 | In distribution | |
| 6339-3542 | In distribution | |
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| 6337-3530 | In distribution | |
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| 6318-4028 | In distribution | |
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| 6337-4034 | In distribution | |
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| 6339-4042 | In distribution | |
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| 6313-4028 | In distribution | |
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| 6338-4030 | In distribution | |
| 6338-4010 | In distribution | |
| 6330-4036 | In distribution | |
| 6336-3550 | In distribution | |
| 6337-4042 | In distribution | |
| 6321-3590 | In distribution | |
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| 6335-3526 | In distribution | |
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| 6338-4024 | In distribution | |
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| 6315-4010 | In distribution | |
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| 6339-4010 | In distribution | |
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| 6337-3524 | In distribution | |
| 6335-3518 | In distribution | |
| 6313-3514 | In distribution | |
| 6310-4036 | In distribution | |
| 6317-4010 | In distribution | |
| 6336-3528 | In distribution | |
| 6335-3514 | In distribution | |
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| 6339-4036 | In distribution | |
| 6311-4016 | In distribution | |
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| 6336-3530 | In distribution | |
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| 6335-4030 | In distribution | |
| 6338-4022 | In distribution | |
| 6336-4048 | In distribution | |
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| 6337-4026 | In distribution | |
| 6337-3546 | In distribution | |
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| 6312-4018 | In distribution | |
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| 6335-4034 | In distribution | |
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| 6319-4032 | In distribution | |
| 6313-3528 | In distribution | |
| 6314-3540 | In distribution | |
| 6315-4022 | In distribution | |
| 6335-4012 | In distribution | |
| 6330-3550 | In distribution | |
| 6339-3550 | In distribution | |
| 6318-3534 | In distribution | |
| 6315-4050 | In distribution | |
| 6314-4014 | In distribution | |
| 6335-4038 | In distribution | |
| 6311-4042 | In distribution | |
| 6330-4030 | In distribution | |
| 6339-3546 | In distribution | |
| 6319-4036 | In distribution | |
| 6330-4038 | In distribution | |
| 6339-4030 | In distribution | |
| 6312-3530 | In distribution | |
| 6315-4014 | In distribution | |
| 6313-4022 | In distribution | |
| 6330-4044 | In distribution | |
| 6313-4036 | In distribution | |
| 6316-4042 | In distribution | |
| 6317-4030 | In distribution | |
| 6319-3544 | In distribution | |
| 6317-3526 | In distribution | |
| 6319-3536 | In distribution | |
| 6337-4024 | In distribution | |
| 6314-4046 | In distribution | |
| 6339-4014 | In distribution | |
| 6315-4038 | In distribution | |
| 6311-3550 | In distribution | |
| 6311-4020 | In distribution | |
| 6337-4018 | In distribution | |
| 6339-4028 | In distribution | |
| 6310-4044 | In distribution | |
| 6339-3516 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Perla ® | Spineart SA | 349 |
Showing 12 of 336. All products under Posterior Cervical Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231840 | 2023-07-20 |
| K200793 | 2020-10-08 |
| K162136 | 2016-11-03 |
| K153439 | 2016-07-21 |
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.