MATORTHO LTD

Address:19/20 Mole Business Park,Leatherhead Surrey,GB

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (9) Camera, Cine, Surgical, Without Audio (FWH) (1)

Premarket Exempt

Clear

SAIPH® - 05055455519398 Catalog Number : 293-702

Device Description : Saiph® Trial Bearing Yellow. Left.14mm

Device Class : 2

Duns Number: 216819863

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SAIPH® - 05055455519404 Catalog Number : 293-703

Device Description : Saiph® Trial Bearing Yellow. Left.16mm

Device Class : 2

Duns Number: 216819863

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SAIPH® - 05055455519411 Catalog Number : 293-704

Device Description : Saiph® Trial Bearing Yellow. Left.18mm

Device Class : 1

Duns Number: 216819863

Premarket Exempt : No

Product Code : FWH

Prescription Use : Yes

Device Count : 1

SAIPH® - 05055455519428 Catalog Number : 293-705

Device Description : Saiph® Trial Bearing Yellow. Left.20mm

Device Class : 2

Duns Number: 216819863

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SAIPH® - 05055455519435 Catalog Number : 293-706

Device Description : Saiph® Trial Bearing Yellow. Right.10mm

Device Class : 2

Duns Number: 216819863

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SAIPH® - 05055455519442 Catalog Number : 293-707

Device Description : Saiph® Trial Bearing Yellow. Right.12mm.Reusable Class IIa instruments use for S Saiph® Trial Bearing Yellow. Right.12mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.

Device Class : 2

Duns Number: 216819863

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SAIPH® - 05055455519459 Catalog Number : 293-708

Device Description : Saiph® Trial Bearing Yellow. Right.14mm.Reusable Class IIa instruments use for S Saiph® Trial Bearing Yellow. Right.14mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.

Device Class : 2

Duns Number: 216819863

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SAIPH® - 05055455519466 Catalog Number : 293-709

Device Description : Saiph® Trial Bearing Yellow. Right.16mm.Reusable Class IIa instruments use for S Saiph® Trial Bearing Yellow. Right.16mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.

Device Class : 2

Duns Number: 216819863

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SAIPH® - 05055455519473 Catalog Number : 293-710

Device Description : Saiph® Trial Bearing Yellow. Right.18mm.Reusable Class IIa instruments use for S Saiph® Trial Bearing Yellow. Right.18mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.

Device Class : 2

Duns Number: 216819863

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

SAIPH® - 05055455519480 Catalog Number : 293-711

Device Description : Saiph® Trial Bearing Yellow. Right.20mm.Reusable Class IIa instruments use for S Saiph® Trial Bearing Yellow. Right.20mm.Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.

Device Class : 2

Duns Number: 216819863

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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