Mariner Deformity
Constrained Pre-Cont Rod, High, Co-Cr, 6.0mm X 450mm
11manufacturers in China registered for this device type
150catalogue 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 | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K211606 |
| Record published | 2023-04-13 |
| Record revised | 2025-10-24 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MD1-535553 | In distribution | |
| MD2-102016 | In distribution | |
| MD1-615450 | In distribution | |
| MF1-175045 | In distribution | |
| MD1-135535 | In distribution | |
| MD1-556042 | In distribution | |
| MD1-515543 | In distribution | |
| MD2-004001 | In distribution | |
| MD1-325560 | In distribution | |
| MD1-526053 | In distribution | |
| MD1-566041 | In distribution | |
| MD3-006002 | In distribution | |
| MD1-646450 | In distribution | |
| MD3-207004 | In distribution | |
| MD2-213080 | In distribution | |
| MD1-566063 | In distribution | |
| MD1-535561 | In distribution | |
| MD1-268580 | In distribution | |
| MF1-255030 | In distribution | |
| MD1-636600 | In distribution | |
| MD1-127555 | In distribution | |
| MD1-117535 | In distribution | |
| MF1-175030 | In distribution | |
| MD1-228570 | In distribution | |
| MD1-126555 | In distribution | |
| MD1-616450 | In distribution | |
| MD3-003002 | In distribution | |
| MD1-545551 | In distribution | |
| MD1-535563 | In distribution | |
| MD1-586042 | In distribution | |
| MD1-515561 | In distribution | |
| MD1-516053 | In distribution | |
| MD3-207001 | In distribution | |
| MD1-525551 | In distribution | |
| MD1-117545 | In distribution | |
| MD3-003003 | In distribution | |
| MD1-125550 | In distribution | |
| MD3-207006 | In distribution | |
| MD3-204002 | In distribution | |
| MD1-575563 | In distribution | |
| MD1-134525 | In distribution | |
| MD3-002003 | In distribution | |
| MD2-211075 | In distribution | |
| MD1-114535 | In distribution | |
| MD1-134535 | In distribution | |
| MD3-006016 | In distribution | |
| MF1-275055 | In distribution | |
| MF1-275045 | In distribution | |
| MD1-516062 | In distribution | |
| MD1-555561 | In distribution | |
| MD1-238570 | In distribution | |
| MD1-525541 | In distribution | |
| MF3-100008 | In distribution | |
| MF1-145040 | In distribution | |
| MD2-211065 | In distribution | |
| MD1-315560 | In distribution | |
| MD1-115550 | In distribution | |
| MD2-102009 | In distribution | |
| MD2-211115 | In distribution | |
| MD1-515541 | In distribution | |
| MD1-134540 | In distribution | |
| MF1-285050 | In distribution | |
| MF1-255035 | In distribution | |
| MD1-300001-14 | In distribution | |
| MD1-516051 | In distribution | |
| MD1-246560 | In distribution | |
| MD1-556061 | In distribution | |
| MD2-102014 | In distribution | |
| MD1-135525 | In distribution | |
| MF1-155030 | In distribution | |
| MF1-145030 | In distribution | |
| MD1-536043 | In distribution | |
| MD1-117540 | In distribution | |
| MD1-655600 | In distribution | |
| MD1-566062 | In distribution | |
| MD1-100027 | In distribution | |
| MD1-236560 | In distribution | |
| MD1-256570 | In distribution | |
| MD3-204005 | In distribution | |
| MD1-117550 | In distribution | |
| MD1-586062 | In distribution | |
| MD3-205015 | In distribution | |
| MF1-245035 | In distribution | |
| MD1-300000-12 | In distribution | |
| MF1-165035 | In distribution | |
| MD1-116555 | In distribution | |
| MD3-006021 | In distribution | |
| MF1-165030 | In distribution | |
| MD1-114525 | In distribution | |
| MD3-208002 | In distribution | |
| MD2-101015 | In distribution | |
| MD1-515542 | In distribution | |
| MD3-205004 | In distribution | |
| MD3-208001 | In distribution | |
| MD1-136530 | In distribution | |
| MD3-205006 | In distribution | |
| MF1-275035 | In distribution | |
| MD3-202001 | In distribution | |
| MD1-247560 | In distribution | |
| MD3-006007 | In distribution | |
| MD1-586041 | In distribution | |
| MF1-185055 | In distribution | |
| MD3-005002 | In distribution | |
| MD3-006005 | In distribution | |
| MF1-155060 | In distribution | |
| MD2-102018 | In distribution | |
| MD1-137540 | In distribution | |
| MD1-114530 | In distribution | |
| MF1-275030 | In distribution | |
| MD2-003012 | In distribution | |
| MD1-137545 | In distribution | |
| MD1-136540 | In distribution | |
| MD1-575561 | In distribution | |
| MD3-207009 | In distribution | |
| MD3-003001 | In distribution | |
| MD3-201004 | In distribution | |
| MD3-006017 | In distribution | |
| MD1-126545 | In distribution | |
| MD1-117555 | In distribution | |
| MD2-103003 | In distribution | |
| MD2-211100 | In distribution | |
| MD1-127550 | In distribution | |
| MF1-175055 | In distribution | |
| MF1-255050 | In distribution | |
| MD1-646600 | In distribution | |
| MD1-575562 | In distribution | |
| MD3-005003 | In distribution | |
| MD2-103004 | In distribution | |
| MD1-555542 | In distribution | |
| MF1-155050 | In distribution | |
| MD1-216580 | In distribution | |
| MD1-556063 | In distribution | |
| MD1-227560 | In distribution | |
| MD2-102008 | In distribution | |
| MD1-136535 | In distribution | |
| MD1-115545 | In distribution | |
| MD3-006029 | In distribution | |
| MD1-135530 | In distribution | |
| MD3-205012 | In distribution | |
| MD1-535543 | In distribution | |
| MD1-526041 | In distribution | |
| MF1-285060 | In distribution | |
| MD1-545553 | In distribution | |
| MD1-115555 | In distribution | |
| MD1-526062 | In distribution | |
| MD3-006023 | In distribution | |
| MD1-536063 | In distribution | |
| MD1-525553 | In distribution | |
| MD3-006012 | In distribution | |
| MF1-165045 | In distribution |
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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Seaspine Orthopedics Corporation | 510(k) number | 2024-02-28 | Class II | Nonconforming Material/Component | Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface. | 444 Screw Heads |
| Seaspine Orthopedics Corporation | 510(k) number | 2024-02-15 | Class II | Nonconforming Material/Component | Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface. | 1579 Screw Heads |
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.