Stanmore Implants Worldwide Ltd

Address:210 Centennial Avenue,Elstree Hertfordshire,GB

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Filters

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, Femorotibial, Constrained, Cemented, Metal/Polymer (KRO) (10)

Premarket Exempt

No Yes

Clear

Instrument - 05060296233822 Catalog Number : IMTIBJIG-PRG

Device Description : Tibial Cutting Guide: Prongs

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233839 Catalog Number : IMGENIMP

Device Description : General Impactor

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233846 Catalog Number : IMTRRHP-SM

Device Description : Rotating Hinge Polyethylene Reamer: Small

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233853 Catalog Number : IMPBIMP-STD

Device Description : Plastic Tibial Bearing Impactor: Standard

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233860 Catalog Number : IMTRRHP-STD

Device Description : Rotating Hinge Polyethylene Reamer: Standard

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233877 Catalog Number : IMPBIMP-SM

Device Description : Plastic Tibial Bearing Impactor: Small

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296234362 Catalog Number : TMKTP-STD20R

Device Description : Trial Tibial Plateau Plate: 20mm Standard

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296234379 Catalog Number : TMKTP-STD15R

Device Description : Trial Tibial Plateau Plate: 15mm Standard

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296234386 Catalog Number : TMKTP-STD10R

Device Description : Trial Tibial Plateau Plate: 10mm Standard

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296234393 Catalog Number : TMKTP-STD5R

Device Description : Trial Tibial Plateau Plate: 5mm Standard

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

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