This page includes the latest FDA filings for Dot America Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3011461101 |
| FEI Number | 3011461101 |
| Name | DOT AMERICA, INC. |
| Owner & Operator | DOT America, Inc. |
| Contact Address | 335 Towerview Drive Columbia City IN 46725 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 335 Towerview Dr Columbia City, IN 46725 US |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
Device Company | Device | Date |
|---|---|---|
DOT AMERICA, INC. | EVOLUTION NitrX Medial-Pivot Knee - prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/pol | 2019-06-06 |
DOT AMERICA, INC. | DJO Surgical | 2017-12-27 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2019031623149 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SLAC 100 PACKAGES ON 2 PALLETS EURO STANDARDI ZED CONTAINER EURO HINGED LID SNAP LOCK HS CO | 100 PCS |
| 2019031418032 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SLAC 100 PACKAGES ON 2 PALLETS EURO STANDARDI ZED CONTAINER EURO HINGED LID SNAP LOCK HS CO | 100 PCS |
| 2019031321872 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SLAC 100 PACKAGES ON 2 PALLETS EURO STANDARDI ZED CONTAINER EURO HINGED LID SNAP LOCK HS CO | 100 PCS |
| 2019031233695 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SLAC 100 PACKAGES ON 2 PALLETS EURO STANDARDI ZED CONTAINER EURO HINGED LID SNAP LOCK HS CO | 100 PCS |
| 2019030140658 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SLAC 100 PACKAGES ON 2 PALLETS EURO STANDARDI ZED CONTAINER EURO HINGED LID SNAP LOCK HS CO | 100 PCS |
| 2018062723289 | Stadersand,Federal Republic of Germany -> Baltimore, Maryland | VPS-SYSTEM 480V 60HZ AS PER OFFER MC17-0611 9 | 11 PCS |
| 2018062723289 | Stadersand,Federal Republic of Germany -> Baltimore, Maryland | VPS SYSTEM 480V/60HZ MC17-06119 | 11 PCS |
| 2018062635891 | Stadersand,Federal Republic of Germany -> Baltimore, Maryland | VPS-SYSTEM 480V 60HZ AS PER OFFER MC17-0611 9 | 11 PCS |
| 2018062635891 | Stadersand,Federal Republic of Germany -> Baltimore, Maryland | VPS SYSTEM 480V/60HZ MC17-06119 | 11 PCS |
| 2018062636577 | Stadersand,Federal Republic of Germany -> Baltimore, Maryland | VPS-SYSTEM 480V/60HZ AS PER OFFER MC17-06119 | 11 PCS |
| 2018062636577 | Stadersand,Federal Republic of Germany -> Baltimore, Maryland | VPS-SYSTEM 480V/60HZ AS PER OFFER MC17-06119 . | 11 PCS |