CastleLoc-S Posterior Cervical Fixation System
Cervical Ploy Axial Screw D5.5, D3.5, L25
4manufacturers in China registered for this device type
82catalogue 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) | K231840 |
| Record published | 2023-08-02 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6202-5550 | In distribution | |
| 6201-5525S | In distribution | |
| 6201-4530S | In distribution | |
| 6201-5030 | In distribution | |
| 6202-5025S | In distribution | |
| 6202-5020S | In distribution | |
| 6202-4525 | In distribution | |
| 6201-4520 | In distribution | |
| 6202-5045 | In distribution | |
| 6201-4545 | In distribution | |
| 6202-5035 | In distribution | |
| 6201-4545S | In distribution | |
| 6201-4550S | In distribution | |
| 6202-4530S | In distribution | |
| 6201-5550 | In distribution | |
| 6202-5525 | In distribution | |
| 6202-4545S | In distribution | |
| 6202-5030 | In distribution | |
| 6202-5520S | In distribution | |
| 6202-4530 | In distribution | |
| 6201-4525S | In distribution | |
| 6202-5035S | In distribution | |
| 6201-5540 | In distribution | |
| 6202-5025 | In distribution | |
| 6202-4525S | In distribution | |
| 6201-4525 | In distribution | |
| 6202-5050 | In distribution | |
| 6201-4520S | In distribution | |
| 6202-4520S | In distribution | |
| 6201-5550S | In distribution | |
| 6202-5030S | In distribution | |
| 6202-5540S | In distribution | |
| 6201-5045 | In distribution | |
| 6202-5530S | In distribution | |
| 6201-4535 | In distribution | |
| 6201-5520S | In distribution | |
| 6202-5530 | In distribution | |
| 6202-5040S | In distribution | |
| 6201-5040S | In distribution | |
| 6202-5535 | In distribution | |
| 6201-5525 | In distribution | |
| 6201-5025S | In distribution | |
| 6202-5545S | In distribution | |
| 6202-4550 | In distribution | |
| 6201-5035S | In distribution | |
| 6202-4520 | In distribution | |
| 6201-4540S | In distribution | |
| 6201-5535 | In distribution | |
| 6202-5550S | In distribution | |
| 6201-4550 | In distribution | |
| 6202-5525S | In distribution | |
| 6201-5020 | In distribution | |
| 6202-5520 | In distribution | |
| 6202-5020 | In distribution | |
| 6201-5540S | In distribution | |
| 6201-4540 | In distribution | |
| 6202-4545 | In distribution | |
| 6201-5530 | In distribution | |
| 6201-5030S | In distribution | |
| 6201-5530S | In distribution | |
| 6201-5050 | In distribution | |
| 6202-5040 | In distribution | |
| 6201-5545 | In distribution | |
| 6201-5045S | In distribution | |
| 6201-4530 | In distribution | |
| 6202-4540S | In distribution | |
| 6201-4535S | In distribution | |
| 6201-5535S | In distribution | |
| 6202-5545 | In distribution | |
| 6201-5545S | In distribution | |
| 6202-5535S | In distribution | |
| 6202-4550S | In distribution | |
| 6202-5540 | In distribution | |
| 6202-4535S | In distribution | |
| 6201-5050S | In distribution | |
| 6201-5020S | In distribution | |
| 6202-4540 | In distribution | |
| 6202-4535 | In distribution | |
| 6201-5520 | In distribution | |
| 6201-5035 | In distribution | |
| 6201-5025 | In distribution | |
| 6202-5050S | In distribution |
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
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.