SAIPH KNEE SYSTEM
MATORTHO
MatOrtho Limited
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016096064 | 3016096064 | MatOrtho Limited | 1 | N | 2026-01-01 | 9a Kay Close Plymton Plymouth Devon GB PL7 4LU |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 235445 | 1105636192 | K140222 | SAIPH KNEE SYSTEM | JWH | 2014-11-17 |
| 235445 | 1715057816 | K020214 | MEDIAL ROTATION KNEE SYSTEM | JWH | 2002-02-26 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JWH | 3 | 2014-11-17 |
PMN#
GUDID#
SAIPH® - Saiph® Tibial Tray Impactor
2021-01-14
SAIPH® - Inset Patella Peg Drill Guide.
2021-01-18
SAIPH® - Saiph® Inset Patella Trial Yellow, Size 16mm. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Inset Patella Trial Red, Size 20mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Inset Patella Trial Blue, Size 24mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Inset Patella Trial Green, Size 28mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph®Cemented Patella Trial 23mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph®Cemented Patella Trial 26mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph®Cemented Patella Trial 30mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph®Cemented Patella Peg Drill Guide.
2021-01-18
SAIPH® - Cemented Inset Peg Drill Guide.
2021-01-18
SAIPH® - Femoral Trial Left, Size 5 Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Femoral Trial Left, Size 6. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Femoral Trial Left, Size 7. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Femoral Trial Left, Size 8. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Femoral Trial Right, Size 1. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Femoral Trial Right, Size 2.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Femoral Trial Right, Size 5.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Femoral Trial Right, Size 6.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Femoral Trial Right, Size 7.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Femoral Trial Right, Size 8
2021-01-18
SAIPH® - Saiph® Trial Bearing Yellow. Right.12mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Yellow. Right.14mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Yellow. Right.16mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Yellow. Right.18mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Yellow. Right.20mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Red. Left.14mm
2021-01-18
SAIPH® - Saiph® Trial Bearing Red. Left.16mm
2021-01-18
SAIPH® - Saiph® Trial Bearing Red. Left.18mm
2021-01-18
SAIPH® - Saiph® Trial Bearing Red. Left.20mm Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Red. Right.10mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Red. Right.12mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Red. Right.14mm. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Red. Right.16mm. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Red. Right.18mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Red. Right.20mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Blue. Left.10mm. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Blue. Left.12mm. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Blue. Left.14mm. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18
SAIPH® - Saiph® Trial Bearing Blue. Left.16mm. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-18