Focus
PS, MIS-Tower Reduction, Cannulated Cortical Cancellous 4.75X50mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization…
PS, MIS-Tower Reduction, Cannulated Cortical Cancellous 4.75X50mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
15manufacturers in China registered for this device type
354catalogue numbers in this listing
1510(k) clearance
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 | Nvision Biomedical Technologies, Inc, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K180458 |
| Record published | 2018-12-15 |
| Record revised | 2026-07-28 (version 5) |
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 |
| Storage | Special storage condition: A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Sizes | Outer diameter 4.75 to 8.5 mm; length 25 to 400 mm |
| Distribution end date | 2025-05-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| L-01-095 | Outer Diameter 5.5 mm | In distribution |
| PDCR-550-025 | Length 25 mm | In distribution |
| PDCM-850-105 | Length 105 mm | In distribution |
| PDCM-550-035 | Length 35 mm | In distribution |
| PDC-650-035 | Length 35 mm | In distribution |
| L-01-045 | Outer Diameter 5.5 mm | In distribution |
| S-01-060 | Outer Diameter 5.5 mm | In distribution |
| S-01-080 | Length 80 mm | In distribution |
| PDCM-650-045 | Length 45 mm | In distribution |
| PDCM-750-045 | Length 45 mm | In distribution |
| PDCM-850-045 | Length 45 mm | In distribution |
| PDCR-475-050 | Outer Diameter 4.75 mm | In distribution |
| PDC-750-045 | Length 45 mm | In distribution |
| PDCR-750-025 | Length 25 mm | In distribution |
| PDCM-850-065 | Length 65 mm | In distribution |
| PDCR-650-060 | Outer Diameter 6.5 mm | In distribution |
| PDCM-550-055 | Length 55 mm | In distribution |
| PDCM-850-035 | Length 35 mm | In distribution |
| PDCR-850-085 | Length 85 mm | In distribution |
| PDCM-850-070 | Outer Diameter 8.5 mm | In distribution |
| S-01-400 | Outer Diameter 5.5 mm | In distribution |
| PDCM-850-095 | Length 95 mm | In distribution |
| PDC-650-055 | Length 55 mm | In distribution |
| PDCM-650-040 | Outer Diameter 6.5 mm | In distribution |
| PDCM-750-025 | Length 25 mm | In distribution |
| S-01-065 | Length 65 mm | In distribution |
| PDC-850-100 | Outer Diameter 8.5 mm | In distribution |
| PDCR-650-025 | Length 25 mm | In distribution |
| PDCR-850-055 | Length 55 mm | In distribution |
| PDC-475-045 | Length 45 mm | In distribution |
| PDC-850-030 | Outer Diameter 8.5 mm | In distribution |
| PDCR-850-110 | Outer Diameter 8.5 mm | In distribution |
| PDC-850-050 | Outer Diameter 8.5 mm | In distribution |
| PDCR-550-040 | Outer Diameter 5.5 mm | In distribution |
| PDCM-650-060 | Outer Diameter 6.5 mm | In distribution |
| S-01-045 | Length 45 mm | In distribution |
| PDCM-475-060 | Outer Diameter 4.75 mm | In distribution |
| PDC-650-050 | Outer Diameter 6.5 mm | In distribution |
| PD-2000-3242 | In distribution | |
| PDC-850-055 | Length 55 mm | In distribution |
| PDC-550-025 | Length 25 mm | In distribution |
| PDCR-650-050 | Outer Diameter 6.5 mm | In distribution |
| L-01-040 | Length 40 mm | In distribution |
| PDCR-550-035 | Length 35 mm | In distribution |
| PDCR-650-055 | Length 55 mm | In distribution |
| L-01-240 | Outer Diameter 5.5 mm | In distribution |
| PDCM-475-030 | Outer Diameter 4.75 mm | In distribution |
| PDC-850-045 | Length 45 mm | In distribution |
| PDCM-475-050 | Outer Diameter 4.75 mm | In distribution |
| PDC-850-035 | Length 35 mm | In distribution |
| PDC-850-110 | Outer Diameter 8.5 mm | In distribution |
| PDCM-550-060 | Outer Diameter 5.5 mm | In distribution |
| PDCR-550-045 | Length 45 mm | In distribution |
| PDCM-750-050 | Outer Diameter 7.5 mm | In distribution |
| PDCR-850-040 | Outer Diameter 8.5 mm | In distribution |
| PDCM-850-085 | Length 85 mm | In distribution |
| PDCR-850-070 | Outer Diameter 8.5 mm | In distribution |
| PDC-475-060 | Outer Diameter 4.75 mm | In distribution |
| S-01-050 | Outer Diameter 5.5 mm | In distribution |
| PDC-850-085 | Length 85 mm | In distribution |
| PDC-650-030 | Outer Diameter 6.5 mm | In distribution |
| S-01-120 | Length 120 mm | In distribution |
| PDCM-850-025 | Length 25 mm | In distribution |
| S-01-090 | Outer Diameter 5.5 mm | In distribution |
| PDCR-850-090 | Outer Diameter 8.5 mm | In distribution |
| PDC-750-060 | Outer Diameter 7.5 mm | In distribution |
| PDC-550-045 | Length 45 mm | In distribution |
| S-01-035 | Length 35 mm | In distribution |
| PDC-750-030 | Outer Diameter 7.5 mm | In distribution |
| PDCM-550-040 | Outer Diameter 5.5 mm | In distribution |
| L-01-080 | Outer Diameter 5.5 mm | In distribution |
| PDCM-850-075 | Length 75 mm | In distribution |
| PDCM-475-025 | Length 25 mm | In distribution |
| PDCM-850-090 | Outer Diameter 8.5 mm | In distribution |
| PDCM-475-055 | Length 55 mm | In distribution |
| L-01-070 | Length 70 mm | In distribution |
| PDCR-750-060 | Outer Diameter 7.5 mm | In distribution |
| L-01-090 | Length 90 mm | In distribution |
| PDCR-850-050 | Outer Diameter 8.5 mm | In distribution |
| PDC-650-045 | Length 45 mm | In distribution |
| PDCR-475-045 | Length 45 mm | In distribution |
| PDCM-650-035 | Length 35 mm | In distribution |
| PDC-850-095 | Length 95 mm | In distribution |
| PDC-850-075 | Length 75 mm | In distribution |
| PDC-850-060 | Outer Diameter 8.5 mm | In distribution |
| PDCM-550-050 | Outer Diameter 5.5 mm | In distribution |
| L-01-120 | Outer Diameter 5.5 mm | In distribution |
| PDCR-750-040 | Outer Diameter 7.5 mm | In distribution |
| PDCM-850-050 | Outer Diameter 8.5 mm | In distribution |
| PDCM-650-050 | Outer Diameter 6.5 mm | In distribution |
| PDCM-750-030 | Outer Diameter 7.5 mm | In distribution |
| PDC-550-030 | Outer Diameter 5.5 mm | In distribution |
| L-01-110 | Length 110 mm | In distribution |
| PDCR-550-060 | Outer Diameter 5.5 mm | In distribution |
| PDC-475-040 | Outer Diameter 4.75 mm | In distribution |
| PDC-475-050 | Outer Diameter 4.75 mm | In distribution |
| S-01-130 | Outer Diameter 5.5 mm | In distribution |
| L-01-035 | Outer Diameter 5.5 mm | In distribution |
| PDCR-550-030 | Outer Diameter 5.5 mm | In distribution |
| PDCM-475-045 | Length 45 mm | In distribution |
| PDCM-850-030 | Outer Diameter 8.5 mm | In distribution |
| PDC-475-055 | Length 55 mm | In distribution |
| PDC-850-090 | Outer Diameter 8.5 mm | In distribution |
| L-01-065 | Outer Diameter 5.5 mm | In distribution |
| PDC-550-050 | Outer Diameter 5.5 mm | In distribution |
| PDC-550-055 | Length 55 mm | In distribution |
| PDC-750-025 | Length 25 mm | In distribution |
| PDCR-650-030 | Outer Diameter 6.5 mm | In distribution |
| PDC-650-025 | Length 25 mm | In distribution |
| PDCR-475-025 | Length 25 mm | In distribution |
| S-00-001 | In distribution | |
| PDCR-750-045 | Length 45 mm | In distribution |
| PDC-550-060 | Outer Diameter 5.5 mm | In distribution |
| PDCM-750-055 | Length 55 mm | In distribution |
| PDCR-550-050 | Outer Diameter 5.5 mm | In distribution |
| PDCM-750-060 | Outer Diameter 7.5 mm | In distribution |
| PDC-750-035 | Length 35 mm | In distribution |
| PDCR-750-055 | Length 55 mm | In distribution |
| PDC-475-035 | Length 35 mm | In distribution |
| PDCM-850-060 | Outer Diameter 8.5 mm | In distribution |
| PD-2000-4258 | In distribution | |
| PDCR-850-075 | Length 75 mm | In distribution |
| PDCR-850-030 | Outer Diameter 8.5 mm | In distribution |
| PDCR-850-025 | Length 25 mm | In distribution |
| PDCM-475-035 | Length 35 mm | In distribution |
| PDCM-850-100 | Outer Diameter 8.5 mm | In distribution |
| S-01-110 | Outer Diameter 5.5 mm | In distribution |
| PDCM-850-055 | Length 55 mm | In distribution |
| S-01-070 | Outer Diameter 5.5 mm | In distribution |
| PDCR-850-095 | Length 95 mm | In distribution |
| S-01-100 | Length 100 mm | In distribution |
| PDCM-550-045 | Length 45 mm | In distribution |
| PDCM-650-030 | Outer Diameter 6.5 mm | In distribution |
| PDCR-850-060 | Outer Diameter 8.5 mm | In distribution |
| PDCR-650-040 | Outer Diameter 6.5 mm | In distribution |
| PDC-750-055 | Length 55 mm | In distribution |
| PDCR-750-035 | Length 35 mm | In distribution |
| PDC-475-030 | Outer Diameter 4.75 mm | In distribution |
| PDCM-850-040 | Outer Diameter 8.5 mm | In distribution |
| L-01-130 | Length 130 mm | In distribution |
| PDC-850-080 | Outer Diameter 8.5 mm | In distribution |
| PDCM-850-080 | Outer Diameter 8.5 mm | In distribution |
| PDCR-850-045 | Length 45 mm | In distribution |
| PDCM-550-025 | Length 25 mm | In distribution |
| S-01-030 | Outer Diameter 5.5 mm | In distribution |
| L-01-050 | Length 50 mm | In distribution |
| PDCR-850-065 | Length 65 mm | In distribution |
| PDCM-475-040 | Outer Diameter 4.75 mm | In distribution |
| PDCR-475-035 | Length 35 mm | In distribution |
| PDC-650-040 | Outer Diameter 6.5 mm | In distribution |
| PDCM-850-110 | Outer Diameter 8.5 mm | In distribution |
| PDCR-750-050 | Outer Diameter 7.5 mm | In distribution |
| PDCR-850-035 | Length 35 mm | In distribution |
| PDCR-650-045 | Length 45 mm | In distribution |
| PDCR-850-080 | Outer Diameter 8.5 mm | In distribution |
| PDCR-475-040 | Outer Diameter 4.75 mm | In distribution |
| PDC-750-050 | Outer Diameter 7.5 mm | In distribution |
| PDC-850-065 | Length 65 mm | In distribution |
| L-01-030 | Length 30 mm | In distribution |
| PDC-550-035 | Length 35 mm | In distribution |
| PDCM-650-025 | Length 25 mm | In distribution |
| PDCR-475-055 | Length 55 mm | In distribution |
| PDC-850-025 | Length 25 mm | In distribution |
| PDCM-750-040 | Outer Diameter 7.5 mm | In distribution |
| PDCR-650-035 | Length 35 mm | In distribution |
| S-01-055 | Length 55 mm | In distribution |
| PDCM-650-055 | Length 55 mm | In distribution |
| PDC-475-025 | Length 25 mm | In distribution |
| L-01-100 | Outer Diameter 5.5 mm | In distribution |
| PDCM-750-035 | Length 35 mm | In distribution |
| PDC-550-040 | Outer Diameter 5.5 mm | In distribution |
| L-01-400 | Length 400 mm | In distribution |
| PDC-850-070 | Outer Diameter 8.5 mm | In distribution |
| PDC-650-060 | Outer Diameter 6.5 mm | In distribution |
| PD-2000-5874 | In distribution | |
| S-01-240 | Length 240 mm | In distribution |
| PDCR-475-030 | Outer Diameter 4.75 mm | In distribution |
| PDCR-475-060 | Outer Diameter 4.75 mm | In distribution |
| PDCR-550-055 | Length 55 mm | In distribution |
| PDCR-750-030 | Outer Diameter 7.5 mm | In distribution |
| PDC-750-040 | Outer Diameter 7.5 mm | In distribution |
| PDC-850-040 | Outer Diameter 8.5 mm | In distribution |
| L-01-060 | Length 60 mm | In distribution |
| PDCR-850-105 | Length 105 mm | In distribution |
| S-01-040 | Outer Diameter 5.5 mm | In distribution |
| L-01-050 | Outer Diameter 5.5 mm | In distribution |
| PDCR-850-100 | Outer Diameter 8.5 mm | In distribution |
| PDC-850-105 | Length 105 mm | In distribution |
| PDCM-550-030 | Outer Diameter 5.5 mm | In distribution |
| PDR-550-040 | Outer Diameter 5.5 mm | Withdrawn |
| PD-850-070 | Outer Diameter 8.5 mm | Withdrawn |
| PDR-850-055 | Length 55 mm | Withdrawn |
| PDR-850-095 | Length 95 mm | Withdrawn |
| PDR-650-035 | Length 35 mm | Withdrawn |
| M-01-080 | Length 80 mm | Withdrawn |
| PDM-650-060 | Outer Diameter 6.5 mm | Withdrawn |
| PDM-750-025 | Length 25 mm | Withdrawn |
| M-01-065 | Length 65 mm | Withdrawn |
| PDR-550-030 | Outer Diameter 5.5 mm | Withdrawn |
| PD-550-035 | Length 35 mm | Withdrawn |
| PD-650-025 | Length 25 mm | Withdrawn |
| PDR-750-035 | Length 35 mm | Withdrawn |
| PDM-750-055 | Length 55 mm | Withdrawn |
| PD-850-065 | Length 65 mm | Withdrawn |
| PDR-750-050 | Outer Diameter 7.5 mm | Withdrawn |
| PD-550-050 | Outer Diameter 5.5 mm | Withdrawn |
| PD-750-040 | Outer Diameter 7.5 mm | Withdrawn |
| PDR-750-030 | Outer Diameter 7.5 mm | Withdrawn |
| PDR-475-025 | Length 25 mm | Withdrawn |
| PD-475-045 | Length 45 mm | Withdrawn |
| PDR-850-090 | Outer Diameter 8.5 mm | Withdrawn |
| PD-475-035 | Length 35 mm | Withdrawn |
| PDR-850-075 | Length 75 mm | Withdrawn |
| PDM-650-025 | Length 25 mm | Withdrawn |
| PDR-550-045 | Length 45 mm | Withdrawn |
| PDR-750-040 | Outer Diameter 7.5 mm | Withdrawn |
| PD-550-060 | Outer Diameter 5.5 mm | Withdrawn |
| PD-475-030 | Outer Diameter 4.75 mm | Withdrawn |
| PDM-850-035 | Length 35 mm | Withdrawn |
| M-01-030 | Outer Diameter 5.5 mm | Withdrawn |
| PDR-650-045 | Length 45 mm | Withdrawn |
| PDR-750-025 | Length 25 mm | Withdrawn |
| M-01-070 | Outer Diameter 5.5 mm | Withdrawn |
| PD-850-030 | Outer Diameter 8.5 mm | Withdrawn |
| PDR-850-025 | Length 25 mm | Withdrawn |
| PD-650-060 | Outer Diameter 6.5 mm | Withdrawn |
| M-01-110 | Outer Diameter 5.5 mm | Withdrawn |
| PDM-550-055 | Length 55 mm | Withdrawn |
| PDR-850-080 | Outer Diameter 8.5 mm | Withdrawn |
| PD-650-045 | Length 45 mm | Withdrawn |
| M-01-040 | Outer Diameter 5.5 mm | Withdrawn |
| PDR-650-055 | Length 55 mm | Withdrawn |
| PDR-750-055 | Length 55 mm | Withdrawn |
| PD-850-040 | Outer Diameter 8.5 mm | Withdrawn |
| PDM-650-030 | Outer Diameter 6.5 mm | Withdrawn |
| PD-750-060 | Outer Diameter 7.5 mm | Withdrawn |
| PDR-850-045 | Length 45 mm | Withdrawn |
| PD-750-050 | Outer Diameter 7.5 mm | Withdrawn |
| PDM-850-095 | Length 95 mm | Withdrawn |
| PDR-750-060 | Outer Diameter 7.5 mm | Withdrawn |
| PD-650-050 | Outer Diameter 6.5 mm | Withdrawn |
| PDR-850-070 | Outer Diameter 8.5 mm | Withdrawn |
| PDR-850-100 | Outer Diameter 8.5 mm | Withdrawn |
| PD-650-055 | Length 55 mm | Withdrawn |
| PDR-850-065 | Length 65 mm | Withdrawn |
| M-01-035 | Length 35 mm | Withdrawn |
| PDM-475-050 | Outer Diameter 4.75 mm | Withdrawn |
| PDR-850-040 | Outer Diameter 8.5 mm | Withdrawn |
| PDR-850-085 | Length 85 mm | Withdrawn |
| M-01-050 | Outer Diameter 5.5 mm | Withdrawn |
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 |
|---|---|
| K180458 | 2018-04-17 |
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.