Atoll
Arched Rod to Rod Cross Connector(55-45mm) Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These…
Arched Rod to Rod Cross Connector(55-45mm) Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient’s pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
11manufacturers in China registered for this device type
86catalogue 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) | K083863 |
| Record published | 2015-09-24 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2019-11-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16-32-4507 | 4.5mm, 7mm | In distribution |
| 16-23-5530 | 3.5mm to 5.5mm | In distribution |
| 16-12-4045 | 4.0mm x 45mm | In distribution |
| 16-32-4011 | 4.0mm, 11mm | In distribution |
| 16-12-3530 | 3.5mm x 30mm | In distribution |
| 16-13-3532 | 3.5mm x 32mm | In distribution |
| 16-21-1804 | small | In distribution |
| 16-13-4024 | 4.0mm x 24mm | In distribution |
| 16-23-5540 | 3.5mm to 5.5mm | In distribution |
| 16-32-4506 | 4.5mm, 6mm | In distribution |
| 16-33-0240 | 110 degrees – 240mm | In distribution |
| 16-12-4512 | 4.5mm x 12mm | In distribution |
| 16-18-1080 | 3.5mm x 80mm | In distribution |
| 16-21-0206 | large | In distribution |
| 16-13-4030 | 4.0mm x 30mm | In distribution |
| 16-30-3848 | large, 38-48mm | In distribution |
| 16-22-0000 | N/A | In distribution |
| 16-12-4508 | 4.5mm x 8mm | In distribution |
| 16-12-3526 | 3.5mm x 26mm | In distribution |
| 16-12-4030 | 4.0mm x 30mm | In distribution |
| 16-22-5545 | 55-45mm | In distribution |
| 16-12-4530 | 4.5mm x 30mm | In distribution |
| 16-18-0000 | 3.5mm to 5.5mm, 385mm | In distribution |
| 16-24-0020 | In distribution | |
| 16-22-4535 | 45-35mm | In distribution |
| 16-13-3526 | 3.5mm x 26mm | In distribution |
| 16-12-4540 | 4.5mm x 40mm | In distribution |
| 16-21-1906 | large | In distribution |
| 16-32-4513 | 4.5mm, 13mm | In distribution |
| 16-12-3545 | 3.5mm x 45mm | In distribution |
| 16-23-5510 | 5.5mm to 3.5mm | In distribution |
| 16-13-4026 | 4.0mm x 26mm | In distribution |
| 16-13-3536 | 3.5mm x 36mm | In distribution |
| 16-22-1048 | 48mm | In distribution |
| 16-21-0205 | medium | In distribution |
| 16-12-4020 | 4.0mm x 20mm | In distribution |
| 16-10-3516 | 3.5mm x 16mm | In distribution |
| 16-12-4040 | 4.0mm x 40mm | In distribution |
| 16-23-3510 | 3.5mm to 3.5mm | In distribution |
| 16-12-3508 | 3.5mm x 8mm | In distribution |
| 16-12-4012 | 4.0mm x 12mm | In distribution |
| 16-12-4545 | 4.5mm x 45mm | In distribution |
| 16-32-4517 | 4.5mm, 17mm | In distribution |
| 16-12-4050 | 4.0mm x 50mm | In distribution |
| 16-12-4008 | 4.0mm x 8mm | In distribution |
| 16-12-3540 | 3.5mm x 40mm | In distribution |
| 16-13-4022 | 4.0mm x 22mm | In distribution |
| 16-32-4008 | 4.0mm, 8mm | In distribution |
| 16-12-3522 | 3.5mm x 22mm | In distribution |
| 16-13-3528 | 3.5mm x 28mm | In distribution |
| 16-12-3514 | 3.5mm x 14mm | In distribution |
| 16-13-4034 | 4.0mm x 34mm | In distribution |
| 16-21-1905 | medium | In distribution |
| 16-12-3535 | 3.5mm x 35mm | In distribution |
| 16-32-4010 | 4.0mm, 10mm | In distribution |
| 16-30-2535 | small, 25-35mm | In distribution |
| 16-13-3520 | 3.5mm x 20mm | In distribution |
| 16-12-3518 | 3.5mm x 18mm | In distribution |
| 16-12-4028 | 4.0mm x 28mm | In distribution |
| 16-13-3522 | 3.5mm x 22mm | In distribution |
| 16-10-4020 | 4.0mm x 20mm | Withdrawn |
| 16-31-4010 | 4.0mm, 10mm | Withdrawn |
| 16-21-0204 | small | Withdrawn |
| 16-10-4024 | 4.0mm x 24mm | Withdrawn |
| 16-31-4008 | 4mm, 8mm | Withdrawn |
| 16-10-4014 | 4.0mm x 14mm | Withdrawn |
| 16-10-4022 | 4.0mm x 22mm | Withdrawn |
| 16-31-4011 | 4.0mm, 11mm | Withdrawn |
| 16-31-4512 | 4.5mm, 12mm | Withdrawn |
| 16-31-4006 | 4.0mm, 6mm | Withdrawn |
| 16-10-3518 | 3.5mm x 18mm | Withdrawn |
| 16-10-3508 | 3.5mm x 8mm | Withdrawn |
| 16-10-3512 | 3.5mm x 12mm | Withdrawn |
| 16-31-4517 | 4.5mm, 17mm | Withdrawn |
| 16-10-4018 | 4.0mm x 18mm | Withdrawn |
| 16-31-4018 | 4.0mm, 18mm | Withdrawn |
| 16-31-4014 | 4.0mm, 14mm | Withdrawn |
| 16-10-3526 | 3.5mm x 26mm | Withdrawn |
| 16-31-4518 | 4.5mm, 18mm | Withdrawn |
| 16-10-3514 | 3.5mm x 14mm | Withdrawn |
| 16-23-3530 | 3.5mm to 3.5mm | Withdrawn |
| 16-31-4513 | 4.5mm, 13mm | Withdrawn |
| 16-10-4008 | 4.0mm x 8mm | Withdrawn |
| 16-31-4507 | 4.5mm, 7mm | Withdrawn |
| 16-31-4511 | 4.5mm, 11mm | Withdrawn |
| 16-10-4010 | 4.0mm x 10mm | 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.