Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| OPTIMA™ Spinal System | SM7055 | CG MedTech Co.,Ltd. | MNI | 08800037558350 |
| OPTIMA™ Spinal System | SPA7055 | CG MedTech Co.,Ltd. | KWQ | 08800015939065 |
| OPTIMA™ Spinal System | SM4040 | CG MedTech Co.,Ltd. | KWQ | 08800015938389 |
| OPTIMA™ Spinal System | SPA7545 | CG MedTech Co.,Ltd. | KWQ | 08800015939164 |
| OPTIMA™ Spinal System | SM7055 | CG MedTech Co.,Ltd. | KWQ | 08800015938471 |
| OPTIMA™ Spinal System | SPA7545 | CG MedTech Co.,Ltd. | MNI | 08800037557889 |
| OPTIMA™ Spinal System | SPA7060 | CG MedTech Co.,Ltd. | KWQ | 08800015939089 |
| OPTIMA™ Spinal System | SM4035 | CG MedTech Co.,Ltd. | KWQ | 08800015938372 |
| OPTIMA™ Spinal System | SM7030 | CG MedTech Co.,Ltd. | MNI | 08800037558305 |
| OPTIMA™ Spinal System | SM7560 | CG MedTech Co.,Ltd. | MNI | 08800037558435 |
| OPTIMA™ Spinal System | SM4045 | CG MedTech Co.,Ltd. | MNI | 08800037558046 |
| OPTIMA™ Spinal System | SM7035 | CG MedTech Co.,Ltd. | MNI | 08800037558312 |
| OPTIMA™ Spinal System | SPA7145 | CG MedTech Co.,Ltd. | MNI | 08800037559845 |
| OPTIMA™ ZS Spinal System | SPA7535 | CG MedTech Co.,Ltd. | MNI | 08800037557865 |
| OPTIMA™ Spinal System | SPA5135 | CG MedTech Co.,Ltd. | KWQ | 08800015932684 |
| OPTIMA™ Spinal System | SP3030 | CG MedTech Co.,Ltd. | MNI | 08800037560551 |
| OPTIMA™ Spinal System | SPA6145 | CG MedTech Co.,Ltd. | KWQ | 08800015938815 |
| OPTIMA™ Spinal System | SM4040 | CG MedTech Co.,Ltd. | MNI | 08800037558039 |
| OPTIMA™ Spinal System | SPA7540 | CG MedTech Co.,Ltd. | KWQ | 08800015932820 |
| OPTIMA™ Spinal System | SPA5125 | CG MedTech Co.,Ltd. | KWQ | 08800015938624 |
| OPTIMA™ Spinal System | SPA7070 | CG MedTech Co.,Ltd. | KWQ | 08800015932769 |
| OPTIMA™ Spinal System | SM7560 | CG MedTech Co.,Ltd. | KWQ | 08800015932622 |
| OPTIMA™ Spinal System | SM7035 | CG MedTech Co.,Ltd. | KWQ | 08800015932479 |
| OPTIMA™ Spinal System | SM7045 | CG MedTech Co.,Ltd. | MNI | 08800037558336 |
| OPTIMA™ Spinal System | SM7030 | CG MedTech Co.,Ltd. | KWQ | 08800015932462 |