Nova Minimally Invasive System
NOVA Minimally Invasive System is a spinal fixation construct of cannulated polyaxial screws, straight or prebent rods and set screws. It provides stabilization of thoracic, lumbar and…
NOVA Minimally Invasive System is a spinal fixation construct of cannulated polyaxial screws, straight or prebent rods and set screws. It provides stabilization of thoracic, lumbar and sacral segments as an adjunct to fusion.
The implants are made from Ti-6Al-4V titanium alloy. Different screw lengths and diameters allow the construct to be assembled around the patient’s anatomy.
Listed Item
Inside Hex Locking Screw
Placement and Compatibility
The system supports percutaneous and mini-open surgery. Screw options range from 5.5 to 7.0 mm in diameter and 20 to 70 mm in length. Components and metals from another manufacturer’s system are not specified for combination with NOVA implants.
15manufacturers in China registered for this device type
174catalogue numbers in this listing
4510(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 | Baui Biotech Co., Ltd., Taiwan |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K242899 |
| Record published | 2025-01-09 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 663-6240Y | In distribution | |
| 663-6570D | In distribution | |
| 663-6570A | In distribution | |
| 663-7055A | In distribution | |
| 320-5521C | In distribution | |
| 663-6245A | In distribution | |
| 663-6565Y | In distribution | |
| 663-7050A | In distribution | |
| 663-5560D | In distribution | |
| 663-6250Y | In distribution | |
| 320-5511C | In distribution | |
| 663-6030D | In distribution | |
| 663-5570D | In distribution | |
| 320-5507C | In distribution | |
| 663-6565C | In distribution | |
| 663-6055A | In distribution | |
| 663-7035Y | In distribution | |
| 663-5540D | In distribution | |
| 663-6030C | In distribution | |
| 663-6545C | In distribution | |
| 663-7060C | In distribution | |
| 663-6540C | In distribution | |
| 663-6550A | In distribution | |
| 663-6555A | In distribution | |
| 663-6040C | In distribution | |
| 320-5575C | In distribution | |
| 663-5555Y | In distribution | |
| 663-5530Y | In distribution | |
| 663-6240C | In distribution | |
| 663-6055Y | In distribution | |
| 663-6560Y | In distribution | |
| 663-5555A | In distribution | |
| 320-5517C | In distribution | |
| 663-6570C | In distribution | |
| 663-5550A | In distribution | |
| 663-7040Y | In distribution | |
| 663-5535C | In distribution | |
| 663-6030A | In distribution | |
| 663-5550D | In distribution | |
| 663-6530Y | In distribution | |
| 663-6565A | In distribution | |
| 663-6040Y | In distribution | |
| 663-5520D | In distribution | |
| 663-5535D | In distribution | |
| 663-5560C | In distribution | |
| 663-6060C | In distribution | |
| 663-5545Y | In distribution | |
| 663-6550Y | In distribution | |
| 663-6035A | In distribution | |
| 663-6545D | In distribution | |
| 663-7045C | In distribution | |
| 663-6050C | In distribution | |
| 320-5515C | In distribution | |
| 663-6535C | In distribution | |
| 663-6555D | In distribution | |
| 320-5555C | In distribution | |
| 663-7030D | In distribution | |
| 663-5520A | In distribution | |
| 663-6030Y | In distribution | |
| 320-5506C | In distribution | |
| 663-7050Y | In distribution | |
| 320-5585C | In distribution | |
| 663-5525D | In distribution | |
| 663-6555Y | In distribution | |
| 663-7050C | In distribution | |
| 663-6060A | In distribution | |
| 663-6045D | In distribution | |
| 663-5540A | In distribution | |
| 663-6550D | In distribution | |
| 663-5570C | In distribution | |
| 663-6520C | In distribution | |
| 663-7050D | In distribution | |
| 663-5555C | In distribution | |
| 663-6535A | In distribution | |
| 663-5560A | In distribution | |
| 663-6530A | In distribution | |
| 663-6250A | In distribution | |
| 663-7040C | In distribution | |
| 663-7035A | In distribution | |
| 320-5523C | In distribution | |
| 663-6545Y | In distribution | |
| 663-5545A | In distribution | |
| 663-6525D | In distribution | |
| 663-5525C | In distribution | |
| 663-6530D | In distribution | |
| 663-6045C | In distribution | |
| 663-5540C | In distribution | |
| 663-7030Y | In distribution | |
| 663-5530A | In distribution | |
| 663-6035D | In distribution | |
| 663-6240A | In distribution | |
| 663-7060Y | In distribution | |
| 663-5520Y | In distribution | |
| 663-6240D | In distribution | |
| 663-5570Y | In distribution | |
| 320-5545C | In distribution | |
| 320-5504C | In distribution | |
| 663-6530C | In distribution | |
| 663-7035C | In distribution | |
| 663-7055D | In distribution | |
| 663-6250C | In distribution | |
| 320-5510C | In distribution | |
| 663-6525Y | In distribution | |
| 320-5565C | In distribution | |
| 663-6245C | In distribution | |
| 663-6540D | In distribution | |
| 663-5525A | In distribution | |
| 663-5545D | In distribution | |
| 320-5509C | In distribution | |
| 663-5530C | In distribution | |
| 663-6040A | In distribution | |
| 663-6570Y | In distribution | |
| 663-6550C | In distribution | |
| 663-6060D | In distribution | |
| 663-6050D | In distribution | |
| 663-5525Y | In distribution | |
| 320-5512C | In distribution | |
| 663-6055C | In distribution | |
| 663-7055C | In distribution | |
| 663-7060D | In distribution | |
| 320-5513C | In distribution | |
| 663-6535Y | In distribution | |
| 663-7030A | In distribution | |
| 663-6035Y | In distribution | |
| 663-6525A | In distribution | |
| 663-6245Y | In distribution | |
| 663-6250D | In distribution | |
| 320-5519C | In distribution | |
| 663-5520C | In distribution | |
| 156-1216 | In distribution | |
| 663-5535A | In distribution | |
| 663-5545C | In distribution | |
| 663-6555C | In distribution | |
| 663-5550C | In distribution | |
| 663-6050A | In distribution | |
| 663-6520D | In distribution | |
| 663-6560D | In distribution | |
| 663-6565D | In distribution | |
| 663-7055Y | In distribution | |
| 320-5508C | In distribution | |
| 663-5550Y | In distribution | |
| 663-6245D | In distribution | |
| 663-6535D | In distribution | |
| 663-6040D | In distribution | |
| 663-6560C | In distribution | |
| 663-5570A | In distribution | |
| 663-5530D | In distribution | |
| 663-6520Y | In distribution | |
| 663-5540Y | In distribution | |
| 320-5525C | In distribution | |
| 320-5505C | In distribution | |
| 663-5555D | In distribution | |
| 663-6520A | In distribution | |
| 663-7035D | In distribution | |
| 663-6045A | In distribution | |
| 663-5535Y | In distribution | |
| 663-6540A | In distribution | |
| 663-7045Y | In distribution | |
| 663-7045A | In distribution | |
| 663-6055D | In distribution | |
| 663-7045D | In distribution | |
| 663-6060Y | In distribution | |
| 663-7040A | In distribution | |
| 663-6035C | In distribution | |
| 663-5560Y | In distribution | |
| 663-7060A | In distribution | |
| 663-6525C | In distribution | |
| 663-7040D | In distribution | |
| 663-6545A | In distribution | |
| 663-7030C | In distribution | |
| 663-6050Y | In distribution | |
| 663-6045Y | In distribution | |
| 663-6540Y | In distribution | |
| 663-6560A | 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 |
|---|---|
| K242899 | 2024-10-17 |
| K191494 | 2019-08-12 |
| K182416 | 2019-06-11 |
| K161231 | 2017-01-23 |
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.