Unimax
Horizontal Plate Offset B Type 42.5 MM
13manufacturers in China registered for this device type
62catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | Paramount Surgicals, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K014302 |
| Record published | 2016-11-01 |
| Record revised | 2025-11-20 (version 6) |
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 |
| Sizes | Length 31 to 120 mm; outer diameter 5.5 to 7 mm; angle 0 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 110-5550 | Length 50 mm | In distribution |
| 114-590 | Length 59 mm | In distribution |
| 112-650B | Length 65 mm | In distribution |
| 110-7050 | Length 50 mm | In distribution |
| 112-550 | Length 55 mm | In distribution |
| 122-17 | In distribution | |
| 114-100 | Length 100 mm | In distribution |
| 118-00 | Angle 0 ° | In distribution |
| 110-6040 | Length 40 mm | In distribution |
| 116-790 | Length 79 mm | In distribution |
| 110-6540 | Length 40 mm | In distribution |
| 110-6050 | Length 50 mm | In distribution |
| 112-625 | Length 62.5 mm | In distribution |
| 110-6550 | Length 50 mm | In distribution |
| 110-7040 | Length 40 mm | In distribution |
| 112-425B | Length 42.5 mm | In distribution |
| 122-16A | In distribution | |
| 114-113 | Length 113 mm | In distribution |
| 110-6545 | Length 45 mm | In distribution |
| 114-860 | Length 86 mm | In distribution |
| 114-720 | Length 72 mm | In distribution |
| 112-650 | Length 65 mm | In distribution |
| 112-475 | Length 47.5 mm | In distribution |
| 112-600B | Length 60 mm | In distribution |
| 150-20 | In distribution | |
| 114-310 | Length 31 mm | In distribution |
| 116-930 | Length 93 mm | In distribution |
| 112-550B | Length 55 mm | In distribution |
| 114-450 | Length 45 mm | In distribution |
| 116-650 | Length 65 mm | In distribution |
| 112-575B | Length 57.5 mm | In distribution |
| 112-675 | Length 67.5 mm | In distribution |
| 112-575 | Length 57.5 mm | In distribution |
| 116-106 | Length 106 mm | In distribution |
| 122-18B | In distribution | |
| 122-18 | In distribution | |
| 120-12 | In distribution | |
| 112-500B | Length 50 mm | In distribution |
| 116-120 | Length 120 mm | In distribution |
| 120-10 | In distribution | |
| 112-475B | Length 47.5 mm | In distribution |
| 112-450B | Length 45 mm | In distribution |
| 112-425 | Length 42.5 mm | In distribution |
| 112-450 | Length 45 mm | In distribution |
| 116-520 | Length 52 mm | In distribution |
| 112-525 | Length 52.5 mm | In distribution |
| 112-625B | Length 62.5 mm | In distribution |
| 112-500 | Length 50 mm | In distribution |
| 116-380 | Length 38 mm | In distribution |
| 112-700 | Length 70 mm | In distribution |
| 110-5540 | Length 40 mm | In distribution |
| 110-6045 | Length 45 mm | In distribution |
| 110-7045 | Length 45 mm | In distribution |
| 124-03 | In distribution | |
| 112-525B | Length 52.5 mm | In distribution |
| 112-725B | Length 72.5 mm | In distribution |
| 150-16 | In distribution | |
| 150-18 | In distribution | |
| 112-700B | Length 70 mm | In distribution |
| 112-725 | Length 72.5 mm | In distribution |
| 112-675B | Length 67.5 mm | In distribution |
| 110-5545 | Length 45 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
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.