visionare.usCranioMaxillofacial Fixation (CMF) System - CMF Visionare
Visionare LLC
VISIONARE LLC
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011196443 | 3011196443 | VISIONARE LLC | 1 | Y | 2026-01-01 | 12220 ITEC Haul Dr Units 215/216 Fort Myers FL US 33913 |
GUDID Contact Samples
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00810004510029 | CMF VISIONARE - 2 Hole Medium Straight Miniplate, T0.7mm | +1 239-244-2973 | customerservice@visionare.us |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 175890 | 1629306102 | K180204 | CranioMaxillofacial Fixation (CMF) System - CMF Visionare | JEY | 2018-12-28 |
| 175890 | 1017335124 | ||||
| 175890 | 1175862869 | ||||
| 175890 | 1440027889 | ||||
| 175890 | 1553402696 | ||||
| 175890 | 1638181068 | ||||
| 175890 | 1672146478 | ||||
| 175890 | 1755924778 | ||||
| 175890 | 1767025202 | ||||
| 175890 | 1848157908 | ||||
| 175890 | 2003409587 | ||||
| 175890 | 2039487081 | ||||
| 175890 | 2068614820 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JEY | 1 | 2018-12-28 |
PMN
GUDID
CMF VISIONARE - Paulus Miniplate, 8mm Offset
2019-02-20
CMF VISIONARE - 2 Hole Medium Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 2 Hole Long Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 4 Hole Regular Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 4 Hole Medium Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 4 Hole Long Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 6 Hole Regular Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 6 Hole Medium Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 6 Hole Long Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 8 Hole Regular Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 8 Hole Medium Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 8 Hole Long Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 12 Hole Regular Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 16 Hole Regular Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 20 Hole Regular Straight Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 2x2 Hole Rectangular Miniplate, 10x7mm, T0.7mm
2019-02-13
CMF VISIONARE - 2x2 Hole Rectangular Miniplate, 10x10mm, T0.7mm
2019-02-13
CMF VISIONARE - 2x3 Hole Rectangular Miniplate, 10x17mm, T0.7mm
2019-02-13
CMF VISIONARE - 2x4 Hole Rectangular Miniplate, 10x24mm, T0.7mm
2019-02-13
CMF VISIONARE - 4 Hole X Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 3x2 Hole Regular T Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 3x2 Hole Medium T Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 3x2 Hole Long T Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 3x2 Hole Extra Long T Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 3x3 Hole Regular T Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 3x3 Hole Medium T Miniplate, T0.7mm
2019-02-13
CMF VISIONARE - 3x3 Hole Long T Miniplate, T0.7mm
2019-02-14
CMF VISIONARE - 3x3 Hole Extra Long T Miniplate, T0.7mm
2019-02-14
CMF VISIONARE - 3x4 Hole Regular T Miniplate, T0.7mm
2019-02-14
CMF VISIONARE - 3x4 Hole Medium T Miniplate, T0.7mm
2019-02-14
CMF VISIONARE - 3x4 Hole Long T Miniplate, T0.7mm
2019-02-14
CMF VISIONARE - 3x4 Hole Extra Long T Miniplate, T0.7mm
2019-02-14
CMF VISIONARE - 3x3 Hole Regular Y Miniplate, T0.7mm
2019-02-14
CMF VISIONARE - 3x3 Hole Medium Y Miniplate, T0.7mm
2019-02-14
CMF VISIONARE - 3x3 Hole Long Y Miniplate, T0.7mm
2019-02-14
CMF VISIONARE - 3x3 Hole Extra Long Y Miniplate, T0.7mm
2019-02-14
CMF VISIONARE - 5x4 Hole Regular Y Miniplate, T0.7mm
2019-02-14
CMF VISIONARE - 5x4 Hole Medium Y Miniplate, T0.7mm
2019-02-14
CMF VISIONARE - 5x4 Hole Long Y Miniplate, T0.7mm
2019-02-14
CMF VISIONARE - 5x4 Hole Extra Long Y Miniplate, T0.7mm
2019-02-14