Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K201136
Cure Lumbar Plate System · Meditech Spine, LLC · decided 2020-05-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CURE OPEL-L (S) | 9-00021-28 | MEDITECH SPINE, LLC | KWQ | B167900021280 |
| CURE OPEL-L | 900-442-26-T | MEDITECH SPINE, LLC | KWQ | B16790044226T0 |
| CURE OPEL-L | 900-421-42-T | MEDITECH SPINE, LLC | KWQ | B16790042142T0 |
| CURE OPEL-L (S) | S1-9-00021-25 | MEDITECH SPINE, LLC | KWQ | B167S1900021250 |
| CURE OPEL-L | 900-442-35-T | MEDITECH SPINE, LLC | KWQ | B16790044235T0 |
| CURE OPEL-L | 900-442-29-T | MEDITECH SPINE, LLC | KWQ | B16790044229T0 |
| CURE OPEL-L (S) | S1-9-00021-44 | MEDITECH SPINE, LLC | KWQ | B167S1900021440 |
| CURE OPEL-L | 900-442-28-T | MEDITECH SPINE, LLC | KWQ | B16790044228T0 |
| CURE OPEL-L (S) | 9-00021-25 | MEDITECH SPINE, LLC | KWQ | B167900021250 |
| CURE OPEL-L (S) | 9-00021-36 | MEDITECH SPINE, LLC | KWQ | B167900021360 |
| CURE OPEL-L (S) | 9-00021-38 | MEDITECH SPINE, LLC | KWQ | B167900021380 |
| CURE OPEL-L | 900-442-33-T | MEDITECH SPINE, LLC | KWQ | B16790044233T0 |
| CURE OPEL-L (S) | 9-00021-40 | MEDITECH SPINE, LLC | KWQ | B167900021400 |
| CURE OPEL-L | 900-421-38-T | MEDITECH SPINE, LLC | KWQ | B16790042138T0 |
| CURE OPEL-L | 900-421-40-T | MEDITECH SPINE, LLC | KWQ | B16790042140T0 |
| CURE OPEL-L | 900-442-42-T | MEDITECH SPINE, LLC | KWQ | B16790044242T0 |
| CURE OPEL-L (S) | 9-00021-34 | MEDITECH SPINE, LLC | KWQ | B167900021340 |
| CURE OPEL-L (S) | S1-9-00021-31 | MEDITECH SPINE, LLC | KWQ | B167S1900021310 |
| CURE OPEL-L | 900-421-00-T | MEDITECH SPINE, LLC | KWQ | B16790042100T0 |
| CURE OPEL-L | 900-442-34-T | MEDITECH SPINE, LLC | KWQ | B16790044234T0 |
| CURE OPEL-L | 900-421-00-01-T | MEDITECH SPINE, LLC | KWQ | B1679004210001T0 |
| CURE OPEL-L | 900-442-30-T | MEDITECH SPINE, LLC | KWQ | B16790044230T0 |
| CURE OPEL-L (S) | 9-00021-41 | MEDITECH SPINE, LLC | KWQ | B167900021410 |
| CURE OPEL-L (S) | S1-9-00021-33 | MEDITECH SPINE, LLC | KWQ | B167S1900021330 |
| CURE OPEL-L (S) | S1-9-00021-38 | MEDITECH SPINE, LLC | KWQ | B167S1900021380 |