Optima™ Spinal System
74 catalogue numbers from SPA5030, listed by CG MedTech Co., Ltd., South Korea, under Orthosis, Spinal Pedicle Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
74catalogue 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, Spinal Pedicle Fixation
Record
| Listed by | CG MedTech Co., Ltd., South Korea |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K020279 |
| Record published | 2023-02-12 |
| Record revised | 2025-07-02 (version 4) |
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, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPA5030 | In distribution | |
| SM7030 | In distribution | |
| SP3030 | In distribution | |
| SM4025 | In distribution | |
| SPA6060 | In distribution | |
| SM6040 | In distribution | |
| SPA8030 | In distribution | |
| SPA6045 | In distribution | |
| SPA7560 | In distribution | |
| SM6550 | In distribution | |
| SPA6035 | In distribution | |
| SM6045 | In distribution | |
| SPA7545 | In distribution | |
| SPA8035 | In distribution | |
| SM4020 | In distribution | |
| SPA6055 | In distribution | |
| SM8055 | In distribution | |
| SM6055 | In distribution | |
| SM6535 | In distribution | |
| SM6540 | In distribution | |
| SPA6025 | In distribution | |
| SPA5145 | In distribution | |
| SGA2440 | In distribution | |
| SPA7550 | In distribution | |
| SM7560 | In distribution | |
| SM4030 | In distribution | |
| SM7045 | In distribution | |
| SM4040 | In distribution | |
| SM5045 | In distribution | |
| SM8045 | In distribution | |
| SM6035 | In distribution | |
| SM6030 | In distribution | |
| SM8050 | In distribution | |
| SPA7045C | In distribution | |
| SM5040 | In distribution | |
| SM4045 | In distribution | |
| SM4035 | In distribution | |
| SPA7530 | In distribution | |
| SPA7040 | In distribution | |
| SM7545 | In distribution | |
| SM8040 | In distribution | |
| SM5035 | In distribution | |
| SM8035 | In distribution | |
| SM7050 | In distribution | |
| SPA7540 | In distribution | |
| SM7550 | In distribution | |
| SPA8050 | In distribution | |
| SPA5045 | In distribution | |
| SM5030 | In distribution | |
| SPA5035 | In distribution | |
| SPA7040C | In distribution | |
| SM7040 | In distribution | |
| SM7055 | In distribution | |
| SPA7145 | In distribution | |
| SPA5120 | In distribution | |
| SPA7045 | In distribution | |
| SPA5140 | In distribution | |
| SM6050 | In distribution | |
| SPA6040 | In distribution | |
| SM7535 | In distribution | |
| SPA5125 | In distribution | |
| SM6555 | In distribution | |
| SPA5040 | In distribution | |
| SM7555 | In distribution | |
| SM7035 | In distribution | |
| SPA8045 | In distribution | |
| SPA5135 | In distribution | |
| SM6530 | In distribution | |
| SPA7050 | In distribution | |
| SPA6050 | In distribution | |
| SPA8040 | In distribution | |
| SPA7140 | In distribution | |
| SPA7035 | In distribution | |
| SM6545 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| U&I Corp., America | 510(k) number | 2004-08-10 | Not classified | Other | Threads on a set screw, as a component of a spinal fixation system, may break off during use. | 200 set screws | 2005-11-29 |
| U&I Corp., America | 510(k) number | 2004-01-14 | Not classified | Other | Reports of hex driver tips breaking off or becoming worn or stripped. | 320 units | 2004-03-24 |
| U&I Corp., America | 510(k) number | 2004-01-14 | Not classified | Other | Reports of hex driver tips breaking off or becoming worn or stripped. | 300 units | 2004-03-24 |
| U&I Corp., America | 510(k) number | 2003-08-18 | Not classified | Other | Reports of pieces chipping off the tip of screwdriver during use. | 215 units. | 2003-11-19 |
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.