Calvary Spine Pedicle Screw System
The Calvary Spine rod is a connecting component within a pedicle screw fixation system for the thoracic, lumbar and sacral spine. The screws use 5.5 mm straight or curved rods. Connecting…
The Calvary Spine rod is a connecting component within a pedicle screw fixation system for the thoracic, lumbar and sacral spine. The screws use 5.5 mm straight or curved rods. Connecting components and screws lock into configurations selected for individual anatomical requirements.
The system stabilizes spinal segments as an adjunct to fusion from T1 to S1 or the ilium. In skeletally mature patients, indications include degenerative disc disease, specified degenerative spondylolisthesis, fracture, dislocation, spinal deformity, stenosis, tumor, pseudoarthrosis and failed fusion.
Listed Item
PreLordosed Rod 5.5mm Diameter 240mm length Ti6Al4V
Pediatric Use and Graft
Posterior noncervical pedicle screw fixation is also indicated for specified pediatric progressive spinal deformities, spondylolisthesis or spondylolysis, fracture from tumor or trauma, pseudoarthrosis and failed fusion. Pediatric fixation is limited to a posterior approach. The system is intended for use with autograft or allograft.
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 | Calvary Spine, LLC, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K201568 |
| Record published | 2020-11-24 |
| Record revised | 2025-07-14 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16560 | In distribution | |
| 18580 | In distribution | |
| 18530 | In distribution | |
| 535 | In distribution | |
| 5480 | In distribution | |
| 15555 | In distribution | |
| 17535 | In distribution | |
| 560 | In distribution | |
| 17545 | In distribution | |
| 16545 | In distribution | |
| 530 | In distribution | |
| 550 | In distribution | |
| 545 | In distribution | |
| 17530 | In distribution | |
| 17550 | In distribution | |
| 590 | In distribution | |
| 17555 | In distribution | |
| 570 | In distribution | |
| 16530 | In distribution | |
| 18560 | In distribution | |
| 15525 | In distribution | |
| 18535 | In distribution | |
| 15540 | In distribution | |
| 15535 | In distribution | |
| 16540 | In distribution | |
| 15550 | In distribution | |
| 18550 | In distribution | |
| 580 | In distribution | |
| 5240 | In distribution | |
| 5100 | In distribution | |
| 15560 | In distribution | |
| 18590 | In distribution | |
| 18570 | In distribution | |
| 15530 | In distribution | |
| 850 | In distribution | |
| 1001 | In distribution | |
| 540 | In distribution | |
| 16550 | In distribution | |
| 15545 | In distribution | |
| 18540 | In distribution | |
| 16555 | In distribution | |
| 18545 | In distribution | |
| 16535 | In distribution | |
| 18555 | In distribution | |
| 17560 | In distribution | |
| 17540 | In distribution | |
| 830 | 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 |
|---|---|
| K201568 | 2020-11-12 |
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.