Nautilus
The FDA filing identifies the NAUTILUS Spinal System as a posterior pedicle-screw fixation system for the noncervical spine in skeletally mature patients. Its device description lists rods,…
The FDA filing identifies the NAUTILUS Spinal System as a posterior pedicle-screw fixation system for the noncervical spine in skeletally mature patients.
Its device description lists rods, screws, and cross connectors, with bone-screw assemblies and cross connectors assembled during manufacturing.
Listed Item
1.4mm x 18 inch K-wire, Trochar Tip, Rounded Ends, Stainless Steel
Device Description and Stated Use
The stated purpose is stabilization and immobilization of spinal segments as an adjunct to fusion. The system is made from titanium alloy. Components are not to be used with components from another system or manufacturer.
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 | 2019-11-07 |
| Record revised | 2025-07-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 113-441 | In distribution | |
| 114-514 | In distribution | |
| 148-524 | In distribution | |
| 116-216 | In distribution | |
| 113-364 | In distribution | |
| 112-281 | In distribution | |
| 148-527 | In distribution | |
| 148-518 | In distribution | |
| 2019-0069 | In distribution | |
| 148-433 | In distribution | |
| 113-464 | In distribution | |
| 2019-0072 | In distribution | |
| 148-525 | In distribution | |
| 148-134 | In distribution | |
| 148-530 | In distribution | |
| 148-403 | In distribution | |
| 114-142 | In distribution | |
| 148-314 | In distribution | |
| 148-220 | In distribution | |
| 114-515 | In distribution | |
| 116-403 | In distribution | |
| 148-138 | In distribution | |
| 116-281 | In distribution | |
| 113-338 | In distribution | |
| 113-394 | In distribution | |
| 148-140 | In distribution | |
| 2017-0216 | In distribution | |
| 148-192 | In distribution | |
| 116-231 | In distribution | |
| 113-439 | In distribution | |
| 148-133 | In distribution | |
| 148-137 | In distribution | |
| 148-445 | In distribution | |
| 148-522 | In distribution | |
| 2019-0078 | In distribution | |
| 114-141 | In distribution | |
| 148-531 | In distribution | |
| 112-280 | In distribution | |
| 148-521 | In distribution | |
| 148-432 | In distribution | |
| 148-402 | In distribution | |
| 136-010 | In distribution | |
| 148-124 | In distribution | |
| 113-339-A | In distribution | |
| 114-513 | In distribution | |
| 117-602 | In distribution | |
| 114-517 | In distribution | |
| 116-235 | In distribution | |
| 116-232 | In distribution | |
| 116-256 | In distribution | |
| 148-519 | In distribution | |
| 113-440 | In distribution | |
| 113-495 | In distribution | |
| 148-523 | In distribution | |
| 148-202 | In distribution | |
| 148-136 | In distribution | |
| 114-516 | In distribution | |
| 148-170 | In distribution | |
| 148-135 | In distribution | |
| 148-526 | In distribution | |
| 148-129 | In distribution | |
| 148-201 | In distribution | |
| 2019-0076 | In distribution | |
| 2019-0079 | In distribution |
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.