Nautilus Spinal System
Nautilus is a posterior spinal fixation system of rods, screws and cross-connectors. Pedicle screws anchor the construct to vertebrae, and the connected components stabilize non-cervical…
Nautilus is a posterior spinal fixation system of rods, screws and cross-connectors. Pedicle screws anchor the construct to vertebrae, and the connected components stabilize non-cervical spinal segments as an adjunct to fusion.
Each screw assembly combines a bone screw, head and taper lock assembled during manufacture. Cross-connectors are also supplied assembled. The components are intended to stabilize and maintain alignment while normal healing occurs.
Listed Item
NAUTILUS Monoaxial Screw Assembly, Non Cannulated, 6.5mm x 25mm, T20
Implant Material and Use
The single-use implants are made from Ti-6Al-4V ELI titanium alloy and supplied nonsterile. The system is intended for skeletally mature patients undergoing thoracic or lumbar fixation. Nautilus components are specified for use within their own system, without components from other systems or manufacturers.
15manufacturers in China registered for this device type
574catalogue numbers in this listing
22510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Life Spine, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K111953 |
| Record published | 2019-11-14 |
| Record revised | 2024-12-05 (version 4) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 765-25-5 | In distribution | |
| 650-075 | In distribution | |
| 785-35-5 | In distribution | |
| 455-50-52 | In distribution | |
| 385-45-52 | In distribution | |
| 355-35-5 | In distribution | |
| TNC55-35-5 | In distribution | |
| 485-35-52 | In distribution | |
| 465-30-52 | In distribution | |
| 355-50-5 | In distribution | |
| 114-345-3 | In distribution | |
| CAT55-30-5 | In distribution | |
| CAT55-55-5 | In distribution | |
| 1385-40-52 | In distribution | |
| 148-306 | In distribution | |
| 485-85-5 | In distribution | |
| 2016-0160 | In distribution | |
| 355-30-52 | In distribution | |
| 445-35-52 | In distribution | |
| 385-45-5 | In distribution | |
| 2016-0155 | In distribution | |
| 148-362 | In distribution | |
| 475-90-5 | In distribution | |
| CAT75-35-5 | In distribution | |
| 3556-450 | In distribution | |
| TNC85-35-5 | In distribution | |
| 148-512 | In distribution | |
| 755-40-5 | In distribution | |
| 148-111 | In distribution | |
| 765-35-5 | In distribution | |
| CAT45-55-5 | In distribution | |
| 445-25-4 | In distribution | |
| TNC45-35-5 | In distribution | |
| 465-35-52 | In distribution | |
| 2017-0115 | In distribution | |
| 3550-600 | In distribution | |
| 148-189 | In distribution | |
| 148-309 | In distribution | |
| 1355-30-52 | In distribution | |
| 465-60-5 | In distribution | |
| 1375-30-5 | In distribution | |
| 2017-0061 | In distribution | |
| 465-50-52 | In distribution | |
| 485-50-5 | In distribution | |
| 485-45-5 | In distribution | |
| 355-45-5 | In distribution | |
| 2550-070 | In distribution | |
| 176-005 | In distribution | |
| 375-85-5 | In distribution | |
| 2014-0017 | In distribution | |
| 2014-0143 | In distribution | |
| TNC45-55-5 | In distribution | |
| 2016-0152 | In distribution | |
| CAT65-30-5 | In distribution | |
| 148-162 | In distribution | |
| 148-110 | In distribution | |
| 148-394 | In distribution | |
| 176-003 | In distribution | |
| 2550-110 | In distribution | |
| CAT65-45-5 | In distribution | |
| 1365-35-5 | In distribution | |
| 365-40-5 | In distribution | |
| 1365-55-5 | In distribution | |
| 775-30-5 | In distribution | |
| 2015-0187 | In distribution | |
| 355-40-5 | In distribution | |
| 445-45-4 | In distribution | |
| 2016-0153 | In distribution | |
| 375-40-52 | In distribution | |
| TNC75-75-5 | In distribution | |
| 445-55-4 | In distribution | |
| TNC85-75-5 | In distribution | |
| 2017-0064 | In distribution | |
| 465-35-5 | In distribution | |
| 1375-65-5 | In distribution | |
| 148-520 | In distribution | |
| 1385-45-5 | In distribution | |
| 2550-040 | In distribution | |
| 365-35-5 | In distribution | |
| 385-30-52 | In distribution | |
| 485-40-5 | In distribution | |
| 148-130 | In distribution | |
| 114-344 | In distribution | |
| 148-311 | In distribution | |
| CAT55-50-5 | In distribution | |
| 465-55-5 | In distribution | |
| 445-50-4 | In distribution | |
| 1375-35-52 | In distribution | |
| 650-160 | In distribution | |
| 148-502 | In distribution | |
| 1365-50-5 | In distribution | |
| 385-85-5 | In distribution | |
| 475-35-5 | In distribution | |
| TNC85-80-5 | In distribution | |
| 775-40-5 | In distribution | |
| 2015-0072 | In distribution | |
| 2550-100 | In distribution | |
| 148-356 | In distribution | |
| 1365-35-52 | In distribution | |
| 650-290 | In distribution | |
| CAT75-55-5 | In distribution | |
| 365-45-5 | In distribution | |
| 2017-0048 | In distribution | |
| 1385-65-5 | In distribution | |
| 1345-45-5 | In distribution | |
| 149-2604 | In distribution | |
| 148-505 | In distribution | |
| 2017-0114 | In distribution | |
| 2015-0072-1 | In distribution | |
| 500-500 | In distribution | |
| 114-345-2 | In distribution | |
| 148-118 | In distribution | |
| 1365-45-52 | In distribution | |
| RB101009-AH | In distribution | |
| 2016-0201 | In distribution | |
| 375-45-52 | In distribution | |
| 455-50-5 | In distribution | |
| TNC85-45-5 | In distribution | |
| 148-516 | In distribution | |
| 114-074 | In distribution | |
| 148-358 | In distribution | |
| 1385-30-5 | In distribution | |
| TNC85-50-5 | In distribution | |
| 2012-0039 | In distribution | |
| 445-40-4 | In distribution | |
| 650-090 | In distribution | |
| 136-1030 | In distribution | |
| 475-40-52 | In distribution | |
| 1355-45-52 | In distribution | |
| 375-40-5 | In distribution | |
| 1375-40-52 | In distribution | |
| 2017-0116 | In distribution | |
| 2016-0136 | In distribution | |
| 176-004 | In distribution | |
| 775-55-5 | In distribution | |
| TNC55-45-5 | In distribution | |
| 765-45-5 | In distribution | |
| 2018-0001 | In distribution | |
| 455-45-5 | In distribution | |
| 151-123 | In distribution | |
| 114-345-4 | In distribution | |
| 148-359 | In distribution | |
| 785-50-5 | In distribution | |
| 755-35-5 | In distribution | |
| 1355-35-52 | In distribution | |
| 2012-0073 | In distribution | |
| 148-539 | In distribution | |
| 650-390 | In distribution | |
| 136-1040 | In distribution | |
| 2011-1400-100 | In distribution | |
| 475-65-5 | In distribution | |
| 136-017 | In distribution | |
| 148-500 | In distribution | |
| 385-65-5 | In distribution | |
| TNC85-110-5 | In distribution | |
| 149-2609 | In distribution | |
| 114-345-1 | In distribution | |
| 1355-50-52 | In distribution | |
| 465-45-52 | In distribution | |
| 385-40-5 | In distribution | |
| 1365-55-52 | In distribution | |
| 745-50-4 | In distribution | |
| CAT65-55-5 | In distribution | |
| TNC85-70-5 | In distribution | |
| 148-196 | In distribution | |
| 765-50-5 | In distribution | |
| 148-310 | In distribution | |
| TNC75-35-5 | In distribution | |
| 148-366 | In distribution | |
| 148-142 | In distribution | |
| 148-493 | In distribution | |
| 2017-0092 | In distribution | |
| 485-35-5 | In distribution | |
| 148-173 | In distribution | |
| 345-55-5 | In distribution | |
| 455-40-5 | In distribution | |
| 1385-30-52 | In distribution | |
| TNC75-70-5 | In distribution | |
| CAT55-35-5 | In distribution | |
| 148-513 | In distribution | |
| CAT45-50-5 | In distribution | |
| 475-40-5 | In distribution | |
| 355-50-52 | In distribution | |
| 2017-0009 | In distribution | |
| 375-55-5 | In distribution | |
| 375-60-5 | In distribution | |
| 136-940 | In distribution | |
| 148-346 | In distribution | |
| TNC65-30-5 | In distribution | |
| TNC65-40-5 | In distribution | |
| TNC75-40-5 | In distribution | |
| 475-30-5 | In distribution | |
| 114-128 | In distribution | |
| TNC85-40-5 | In distribution | |
| TNC85-120-5 | In distribution | |
| 2012-0136 | In distribution | |
| CAT65-35-5 | In distribution | |
| 148-116 | In distribution | |
| 385-80-5 | In distribution | |
| 148-540 | In distribution | |
| 475-35-52 | In distribution | |
| 385-35-5 | In distribution | |
| 455-35-52 | In distribution | |
| 445-35-4 | In distribution | |
| 475-50-52 | In distribution | |
| 650-175 | In distribution | |
| TNC75-55-5 | In distribution | |
| 148-175 | In distribution | |
| TNC85-105-5 | In distribution | |
| 365-30-52 | In distribution | |
| TNC45-50-5 | In distribution | |
| 114-108 | In distribution | |
| 148-301 | In distribution | |
| 2016-0156 | In distribution | |
| 1365-30-5 | In distribution | |
| 148-498 | In distribution | |
| 148-392 | In distribution | |
| 655-35-5 | In distribution | |
| TNC75-90-5 | In distribution | |
| TNC85-90-5 | In distribution | |
| 485-65-5 | In distribution | |
| 355-55-5 | In distribution | |
| 148-508 | In distribution | |
| 1355-55-5 | In distribution | |
| 1365-45-5 | In distribution | |
| 148-181 | In distribution | |
| 114-110 | In distribution | |
| CAT65-40-5 | In distribution | |
| TNC55-30-5 | In distribution | |
| 445-25-42 | In distribution | |
| 755-50-5 | In distribution | |
| 375-55-52 | In distribution | |
| 114-171 | In distribution | |
| 148-318 | In distribution | |
| 1375-30-52 | In distribution | |
| 485-60-5 | In distribution | |
| 1385-50-52 | In distribution | |
| 1355-40-5 | In distribution | |
| 2017-0008 | In distribution | |
| 1355-45-5 | In distribution | |
| 485-80-5 | In distribution | |
| 455-30-5 | In distribution | |
| 148-237 | In distribution | |
| 2550-115 | In distribution | |
| 755-55-5 | In distribution | |
| 2018-0050 | In distribution | |
| 2550-060 | In distribution | |
| 2015-0020 | In distribution | |
| 114-520 | In distribution | |
| TNC85-60-5 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254274 | 2026-04-16 |
| K233455 | 2023-12-12 |
| K220341 | 2022-05-02 |
| K220025 | 2022-03-31 |
| K210549 | 2021-04-22 |
| K203163 | 2020-12-17 |
| K200070 | 2020-04-23 |
| K191575 | 2019-08-08 |
| K183430 | 2019-03-13 |
| K151196 | 2015-07-14 |
| K150390 | 2015-03-16 |
| K141222 | 2015-02-12 |
| K140457 | 2014-03-25 |
| K133564 | 2014-02-19 |
| K132866 | 2013-10-28 |
| K132760 | 2013-10-03 |
| K123373 | 2013-03-06 |
| K111953 | 2012-08-07 |
| K111729 | 2011-09-07 |
| K090320 | 2009-07-22 |
| K073480 | 2008-01-04 |
| K070995 | 2007-06-22 |
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.