Cure 2.0 Anterior Cervical Plate (ACP) System
Meditech Spine, LLC
Meditech Spine, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009405289 | 3009405289 | Meditech Spine, LLC | 1 | Y | 2020-04-25 | 1447 Peachtree St NE Ste 440 Atlanta GA US 30309 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 144066 | 1616610323 | K181543 | Cure™ OPEL-C Plate System | KWQ | 2018-08-31 |
| 144066 | 1982889441 | K180090 | Cure™ Lumbar Plate System | KWQ | 2018-04-23 |
| 144066 | 1311840214 | K171538 | Cure™ Lumbar Plate System | KWQ | 2017-06-16 |
| 144066 | 1395048615 | K170395 | Talos® Lumbar (HA) PEEK IBF Devices | MAX | 2017-06-02 |
| 144066 | 2008407122 | K160604 | Cure™ Anterior Cervical Plate (ACP) System | KWQ | 2016-07-01 |
| 144066 | 1042648363 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices | ODP | 2015-10-14 |
| 144066 | 1127832173 | K142345 | Talos-C(HA) Cervical Intervertebral Body Fusion Devices | ODP | 2015-02-22 |
| 144066 | 1925449017 | K122850 | TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES | ODP | 2013-03-28 |
| 144066 | 1525957828 | K090707 | TALOS INTERVERTEBRAL BODY FUSION DEVICE | MAX | 2009-07-15 |
| 144066 | 1411320459 | ||||
| 144066 | 1661354432 |
Product Codes Associated With Registrations#
PMN#
Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
Meditech Spine, LLC
Cure™ Lumbar Plate System
Meditech Spine, LLC
Cure™ OPEL-C Plate System
Meditech Spine, LLC
Cure™ Lumbar Plate System
Meditech Spine, LLC
Cure™ Lumbar Plate System
Meditech Spine, LLC
Talos® Lumbar (HA) PEEK IBF Devices
Meditech Spine, LLC
Cure™ Anterior Cervical Plate (ACP) System
MEDITECH SPINE, LLC
Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices
MEDITECH SPINE, LLC
Talos-C(HA) Cervical Intervertebral Body Fusion Devices
MEDITECH SPINE, LLC
GUDID#
CURE IVIEW - 9-00002-25
2022-10-07
CURE IVIEW - 9-00002-26
2022-10-07
CURE IVIEW - 9-00002-27
2022-10-07
CURE IVIEW - 9-00002-28
2022-10-07
CURE IVIEW - 9-00002-29
2022-10-07
CURE IVIEW - 9-00002-30
2022-10-07
CURE IVIEW - 9-00002-31
2022-10-07
CURE IVIEW - 9-00002-32
2022-10-07
CURE IVIEW - 9-00002-33
2022-10-07
CURE IVIEW - 9-00002-34
2022-10-07
CURE IVIEW - 9-00002-35
2022-10-07
CURE IVIEW - 9-00002-36
2022-10-07
CURE IVIEW - 9-00002-37
2022-10-07
CURE IVIEW - 9-00002-38
2022-10-07
CURE IVIEW - 9-00002-39
2022-10-07
CURE IVIEW - 9-00002-40
2022-10-07
CURE IVIEW - 9-00002-41
2022-10-07
CURE IVIEW - 9-00002-42
2022-10-07
CURE IVIEW - 9-00002-43
2022-10-07
CURE IVIEW - 9-00002-44
2022-10-07
CURE IVIEW - 9-00002-45
2022-10-07
CURE OPEL-L (S) - 9-00021-25
2022-10-07
CURE OPEL-L (S) - 9-00021-26
2022-10-07
CURE OPEL-L (S) - 9-00021-27
2022-10-07
CURE OPEL-L (S) - 9-00021-28
2022-10-07
CURE OPEL-L (S) - 9-00021-29
2022-10-07
CURE OPEL-L (S) - 9-00021-30
2022-10-07
CURE OPEL-L (S) - 9-00021-31
2022-10-07
CURE OPEL-L (S) - 9-00021-32
2022-10-07
CURE OPEL-L (S) - 9-00021-33
2022-10-07
CURE OPEL-L (S) - 9-00021-34
2022-10-07
CURE OPEL-L (S) - 9-00021-35
2022-10-07
CURE OPEL-L (S) - 9-00021-36
2022-10-07
CURE OPEL-L (S) - 9-00021-37
2022-10-07
CURE OPEL-L (S) - 9-00021-38
2022-10-07
CURE OPEL-L (S) - 9-00021-39
2022-10-07
CURE OPEL-L (S) - 9-00021-40
2022-10-07
CURE OPEL-L (S) - 9-00021-41
2022-10-07
CURE OPEL-L (S) - 9-00021-42
2022-10-07
CURE OPEL-L (S) - 9-00021-43
2022-10-07