Pisces Spinal System
Pisces is a modular pedicle-screw system for posterior spinal fixation. It combines solid or cannulated screws with separate tulip heads, rods and set screws to immobilize spinal segments…
Pisces is a modular pedicle-screw system for posterior spinal fixation. It combines solid or cannulated screws with separate tulip heads, rods and set screws to immobilize spinal segments as an adjunct to fusion.
A tulip assembly snaps onto the spherical screw head before or after screw insertion. A rod is placed in the tulip, and a set screw locks the rod, tulip and pedicle screw together. The system accepts 5.5 or 6.0 mm rods.
Listed Item
Modular Cannulated DL Pedicle Screw Diameter 6.5x25mm
Implant Configurations
The titanium implants are supplied sterile for single use. Tulip options include standard, reduction and extended-tab forms. Reduction tabs assist rod reduction, while longer tabs support minimally invasive placement; the guide tabs are removed after final locking.
15manufacturers in China registered for this device type
83catalogue 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 | Ortho Development Corp., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K203023 |
| Record published | 2023-06-09 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 4.5 to 8.5 mm; length 20 to 90 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 753-4545-10A | Length 45 mm | In distribution |
| 753-4550-10A | Length 50 mm | In distribution |
| 753-6525-20 | Outer Diameter 6.5 mm | In distribution |
| 753-0551 | Outer Diameter 5.5 mm | In distribution |
| 753-7540-10A | Outer Diameter 7.5 mm | In distribution |
| 753-4525-10A | Length 25 mm | In distribution |
| 753-8535-20 | Length 35 mm | In distribution |
| 753-7530-20 | Outer Diameter 7.5 mm | In distribution |
| 753-4530-10A | Outer Diameter 4.5 mm | In distribution |
| 753-7550-10A | Outer Diameter 7.5 mm | In distribution |
| 753-6550-20 | Outer Diameter 6.5 mm | In distribution |
| 753-6540-20 | Length 40 mm | In distribution |
| 753-8575-20 | Length 75 mm | In distribution |
| 753-5540-20 | Outer Diameter 5.5 mm | In distribution |
| 753-8575-10A | Length 75 mm | In distribution |
| 753-0552 | Outer Diameter 5.5 mm | In distribution |
| 753-5555-20 | Length 55 mm | In distribution |
| 753-5560-20 | Length 60 mm | In distribution |
| 753-8570-20 | Outer Diameter 8.5 mm | In distribution |
| 753-8545-20 | Length 45 mm | In distribution |
| 753-5545-10A | Length 45 mm | In distribution |
| 753-5555-10A | Outer Diameter 5.5 mm | In distribution |
| 753-5525-10A | Outer Diameter 5.5 mm | In distribution |
| 753-7540-20 | Outer Diameter 7.5 mm | In distribution |
| 753-6540-10A | Length 40 mm | In distribution |
| 753-6530-20 | Outer Diameter 6.5 mm | In distribution |
| 753-8555-20 | Length 55 mm | In distribution |
| 753-7550-20 | Length 50 mm | In distribution |
| 753-8560-10A | Outer Diameter 8.5 mm | In distribution |
| 753-7545-10A | Outer Diameter 7.5 mm | In distribution |
| 753-8545-10A | Length 45 mm | In distribution |
| 753-7535-20 | Outer Diameter 7.5 mm | In distribution |
| 753-6545-10A | Length 45 mm | In distribution |
| 753-7555-20 | Length 55 mm | In distribution |
| 753-8535-10A | Outer Diameter 8.5 mm | In distribution |
| 753-8550-10A | Outer Diameter 8.5 mm | In distribution |
| 753-5535-10A | Length 35 mm | In distribution |
| 753-8555-10A | Outer Diameter 8.5 mm | In distribution |
| 753-5545-20 | Outer Diameter 5.5 mm | In distribution |
| 753-8530-10A | Outer Diameter 8.5 mm | In distribution |
| 753-8560-20 | Outer Diameter 8.5 mm | In distribution |
| 753-7555-10A | Outer Diameter 7.5 mm | In distribution |
| 753-4525-20 | Outer Diameter 4.5 mm | In distribution |
| 753-8570-10A | Outer Diameter 8.5 mm | In distribution |
| 753-4545-20 | Length 45 mm | In distribution |
| 753-5535-20 | Length 35 mm | In distribution |
| 753-8580-20 | Outer Diameter 8.5 mm | In distribution |
| 753-7530-10A | Length 30 mm | In distribution |
| 753-7535-10A | Length 35 mm | In distribution |
| 753-6560-10A | Outer Diameter 6.5 mm | In distribution |
| 753-6530-10A | Length 30 mm | In distribution |
| 753-8565-20 | Outer Diameter 8.5 mm | In distribution |
| 753-4530-20 | Length 30 mm | In distribution |
| 753-8550-20 | Length 50 mm | In distribution |
| 753-6535-10A | Outer Diameter 6.5 mm | In distribution |
| 753-6555-10A | Length 55 mm | In distribution |
| 753-5530-20 | Outer Diameter 5.5 mm | In distribution |
| 753-4540-10A | Outer Diameter 4.5 mm | In distribution |
| 753-6545-20 | Length 45 mm | In distribution |
| 753-5550-10A | Length 50 mm | In distribution |
| 753-6555-20 | Length 55 mm | In distribution |
| 753-8565-10A | Outer Diameter 8.5 mm | In distribution |
| 753-6560-20 | Length 60 mm | In distribution |
| 753-5540-10A | Length 40 mm | In distribution |
| 753-7560-20 | Length 60 mm | In distribution |
| 753-8580-10A | Length 80 mm | In distribution |
| 753-4535-20 | Outer Diameter 4.5 mm | In distribution |
| 753-6525-10A | Outer Diameter 6.5 mm | In distribution |
| 753-6535-20 | Length 35 mm | In distribution |
| 753-8540-10A | Length 40 mm | In distribution |
| 753-5525-20 | Outer Diameter 5.5 mm | In distribution |
| 753-0553 | Length 90 mm | In distribution |
| 753-7545-20 | Length 45 mm | In distribution |
| 753-4540-20 | Outer Diameter 4.5 mm | In distribution |
| 753-5560-10A | Length 60 mm | In distribution |
| 753-5530-10A | Length 30 mm | In distribution |
| 753-6550-10A | Outer Diameter 6.5 mm | In distribution |
| 753-8540-20 | Outer Diameter 8.5 mm | In distribution |
| 753-4535-10A | Outer Diameter 4.5 mm | In distribution |
| 753-4550-20 | Outer Diameter 4.5 mm | In distribution |
| 753-5550-20 | Outer Diameter 5.5 mm | In distribution |
| 753-8530-20 | Length 30 mm | In distribution |
| 753-7560-10A | Length 60 mm | 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 |
|---|---|
| K203023 | 2021-07-14 |
| K162995 | 2017-03-30 |
| K142146 | 2014-12-11 |
| K131785 | 2013-08-20 |
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.