SAIPH KNEE SYSTEM
MATORTHO
MATORTHO
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008985661 | 3008985661 | MATORTHO LIMITED | 1 | N | 2026-01-01 | 19/20 Mole Business Park Randalls Road Leatherhead Surrey GB KT22 7BA |
| 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 |
|---|---|---|---|---|---|
| 129578 | 1105636192 | K140222 | SAIPH KNEE SYSTEM | JWH | 2014-11-17 |
| 235445 | 1105636192 | K140222 | SAIPH KNEE SYSTEM | JWH | 2014-11-17 |
| 129578 | 1715057816 | K020214 | MEDIAL ROTATION KNEE SYSTEM | JWH | 2002-02-26 |
| 235445 | 1715057816 | K020214 | MEDIAL ROTATION KNEE SYSTEM | JWH | 2002-02-26 |
| 129578 | 1650721066 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JWH | 6 | 2014-11-17 |
PMN#
GUDID#
SAIPH® - Femoral Trial Left, Size 1. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.
2021-01-14
SAIPH® - Saiph® Trial Bearing Red. Left.12mm
2021-01-15
SAIPH® - Saiph® Trial Bearing Red. Left.10mm
2021-01-15
SAIPH® - Saiph® Trial Bearing Yellow. Right.10mm
2021-01-15
SAIPH® - Saiph® Trial Bearing Yellow. Left.20mm
2021-01-15
SAIPH® - Saiph® Trial Bearing Yellow. Left.18mm
2021-01-15
SAIPH® - Saiph® Trial Bearing Yellow. Left.16mm
2021-01-15
SAIPH® - Saiph® Trial Bearing Yellow. Left.14mm
2021-01-15
SAIPH® - Saiph® Trial Bearing Yellow. Left.12mm
2021-01-15
SAIPH® - Saiph® Trial Bearing Yellow. Left.10mm
2021-01-15
SAIPH® - Tibial Webbing Chisel Guide C to F
2021-01-15
SAIPH® - Tibial Webbing Chisel Guide A to B
2021-01-15
SAIPH® - Variable Spacer
2021-01-15
SAIPH® - Tibial Webbing Chisel Size 6
2021-01-15
SAIPH® - Tibial Webbing Chisel Size 5
2021-01-15
SAIPH® - Tibial Webbing Chisel Size 4
2021-01-15
SAIPH® - Tibial Webbing Chisel Size 3
2021-01-15
SAIPH® - Tibial Webbing Chisel Size 2
2021-01-15
SAIPH® - Tibial Webbing Chisel Size 1
2021-01-15
SAIPH® - Saiph® Femoral Impactor
2021-01-15
SAIPH® - Saiph® Femoral Spacer. Green
2021-01-15
SAIPH® - Saiph® Femoral Spacer. Blue
2021-01-15
SAIPH® - Saiph® Femoral Spacer. Red
2021-01-15
SAIPH® - Saiph® Femoral Spacer. Yellow
2021-01-15
SAIPH® - Dual Ended Tibial Spacer. 20 mm
2021-01-15
SAIPH® - Dual Ended Tibial Spacer. 18 mm
2021-01-15
SAIPH® - Dual Ended Tibial Spacer. 16 mm
2021-01-15
SAIPH® - Dual Ended Tibial Spacer. 14 mm
2021-01-15
SAIPH® - Dual Ended Tibial Spacer. 12 mm
2021-01-15
SAIPH® - Dual Ended Tibial Spacer . 10 mm
2021-01-15
SAIPH® - Tibial Drill Guide Size F
2021-01-15
SAIPH® - Tibial Drill Guide Size E
2021-01-15
SAIPH® - Tibial Drill Guide Size D
2021-01-15
SAIPH® - Tibial Drill Guide Size C
2021-01-15
SAIPH® - Tibial Drill Guide Size B
2021-01-15
SAIPH® - Tibial Drill Guide Size A
2021-01-15
SAIPH® - Tibial Template Size F
2021-01-15
SAIPH® - Tibial Template Size E
2021-01-15
SAIPH® - Tibial Template Size D
2021-01-15
SAIPH® - Tibial Template Size C
2021-01-15