Mahe Medical GmbH
Polyaxial screw reduct., w/o cannulation_x000D_7.5mm/50mm _x000D_
15manufacturers in China registered for this device type
108catalogue 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 | Mahe Intl., Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2019-11-05 |
| Record revised | 2025-07-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSR11-7550 | In distribution | |
| SCC03-0055 | In distribution | |
| PSS10-16525 | In distribution | |
| PSS11-7550 | In distribution | |
| PSS09-5525 | In distribution | |
| PSS11-7520 | In distribution | |
| PSS09-15520 | In distribution | |
| SCC03-0110 | In distribution | |
| PSS09-5545 | In distribution | |
| PSS11-17540 | In distribution | |
| SCC03-0080 | In distribution | |
| SCC03-0160 | In distribution | |
| PSS10-6550 | In distribution | |
| PSS10-16530 | In distribution | |
| PSR11-7560 | In distribution | |
| PSS11-17520 | In distribution | |
| PSS11-7535 | In distribution | |
| PSS09-5520 | In distribution | |
| SCC03-0050 | In distribution | |
| SCC02-0600 | In distribution | |
| PSS09-15550 | In distribution | |
| PSS09-5530 | In distribution | |
| PSS11-17525 | In distribution | |
| SCC03-0090 | In distribution | |
| SCC03-0045 | In distribution | |
| PSS08-4560 | In distribution | |
| PSS10-6560 | In distribution | |
| SCC02-0040 | In distribution | |
| SCC02-0120 | In distribution | |
| PSS10-16520 | In distribution | |
| PSS09-5535 | In distribution | |
| SCC03-0040 | In distribution | |
| SCC03-0180 | In distribution | |
| SCC0120-0035 | In distribution | |
| SCC02-0500 | In distribution | |
| SCC03-0035 | In distribution | |
| SCC02-0050 | In distribution | |
| PSS09-15530 | In distribution | |
| CHM01-11 | In distribution | |
| PSS08-4545 | In distribution | |
| SCC03-0250 | In distribution | |
| PSS10-6520 | In distribution | |
| SCC02-0200 | In distribution | |
| PSS11-17530 | In distribution | |
| PSS10-16560 | In distribution | |
| PSS08-4525 | In distribution | |
| PSS11-7555 | In distribution | |
| PSS11-17555 | In distribution | |
| PSS08-4555 | In distribution | |
| PSS08-4550 | In distribution | |
| SCC02-0400 | In distribution | |
| PSS11-17560 | In distribution | |
| PSS08-4530 | In distribution | |
| SCC03-0120 | In distribution | |
| PSR11-7555 | In distribution | |
| PSR11-7545 | In distribution | |
| PSS08-4540 | In distribution | |
| PSS09-15535 | In distribution | |
| SCC0120-0050 | In distribution | |
| PSS11-7525 | In distribution | |
| SCC02-0035 | In distribution | |
| SCC02-0045 | In distribution | |
| PSS10-16540 | In distribution | |
| PSS10-16535 | In distribution | |
| PSS10-6540 | In distribution | |
| PSS09-5550 | In distribution | |
| SCC03-0060 | In distribution | |
| PSS11-7545 | In distribution | |
| PSS11-17545 | In distribution | |
| CHM01-10 | In distribution | |
| PSS09-15540 | In distribution | |
| PSS09-5555 | In distribution | |
| PSS09-15545 | In distribution | |
| SCC02-0100 | In distribution | |
| PSS11-17535 | In distribution | |
| SCC02-0080 | In distribution | |
| PSS10-6555 | In distribution | |
| PSS11-7530 | In distribution | |
| PSS08-4535 | In distribution | |
| SCC02-0090 | In distribution | |
| PSS09-5540 | In distribution | |
| PSS10-6530 | In distribution | |
| PSS10-6535 | In distribution | |
| PSS09-5560 | In distribution | |
| SCC03-0070 | In distribution | |
| PSS10-16555 | In distribution | |
| SCC03-0100 | In distribution | |
| SCC0120-0045 | In distribution | |
| SCC03-0110-S | In distribution | |
| PSS10-6545 | In distribution | |
| SCC03-0200 | In distribution | |
| PSS09-15560 | In distribution | |
| SCC02-0450 | In distribution | |
| PSS09-15525 | In distribution | |
| SCC02-0110 | In distribution | |
| SCC0120-0042 | In distribution | |
| SCC03-0140 | In distribution | |
| PSS11-17550 | In distribution | |
| SCC0120-0040 | In distribution | |
| PSS10-16550 | In distribution | |
| PSS09-15555 | In distribution | |
| PSS11-7560 | In distribution | |
| PSS10-16545 | In distribution | |
| SCC02-0055 | In distribution | |
| PSS10-6525 | In distribution | |
| SCC02-0350 | In distribution | |
| PSS11-7540 | In distribution | |
| SCC02-0060 | 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 |
|---|---|
| K110655 | 2011-10-27 |
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.