OTS Hip
Ortoma AB
ORTOMA AB
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014411622 | 3014411622 | ORTOMA AB | 1 | N | 2026-01-01 | Falkenbergsgatan 3 Gothenburg Vastra Gotaland SE 41285 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 331161 | 1224578549 | K232140 | OTS Hip | OLO | 2024-03-11 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OLO | 1 | 2024-03-11 |
PMN
Ortoma Treatment Solution - OTS
Ortoma AB
GUDID
Inserter Adapter OTD Pinnacle Straight - 1001
2024-10-03
Measurement Screw 15 mm - 1001
2024-10-03
Measurement Screw 8 mm - 1001
2024-10-03
Threaded Pin 4x150 mm - 1001
2024-10-03
Inserter Adapter OTD Straight - 1002
2024-10-03
Reamer Adapter OTD - 1003
2024-10-01
OTS Hip Plan - 5
2024-10-01
OTS Hip Guide SW - 5
2024-10-01
Stylet and Pin - 1003
2024-10-01
Pointer Holder - 1002
2024-10-01
Pointer OT - 1002
2024-10-01
Attachment Adapter Fix OT - 1002
2024-10-01
Tracer Set - 1001
2024-10-01
Inserter Adapter OTD - 1004
2024-10-01
Measurement Screw Driver - 1002
2024-10-01
OTS Hip Solution Pinnacle - 1001
2024-10-01
OTS Hip Solution Emphasys - 1001
2024-10-01
OTS Hip Guide Reusable Set Pinnacle - 1001
2024-10-01
OTS Hip Guide Reusable Set Emphasys - 1001
2024-10-01
Attachment Adapter Twin OT - 1006
2024-10-01
Threaded Pin Driver - 1004
2024-10-01
Calibration Adapter Unit OTD - 1003
2024-10-01
Calibration Adapter Unit OTD Emphasys - 1002
2024-10-01
OTS Hip - 1001
2024-10-01