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 - 05060296233709 Catalog Number : IMTRFH

Device Description : Fixed hinge Reamer

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233716 Catalog Number : IMTPRMFH-SM

Device Description : SM Positioning Plate: Holes

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233723 Catalog Number : IMTPRHP-SM

Device Description : SM Positioning Plate: Slots

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233730 Catalog Number : IMTPRMFH-STD

Device Description : STD Positioning Plate: Holes

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233747 Catalog Number : IMTPRHP-STD

Device Description : STD Positioning Plate: Slots

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233754 Catalog Number : IMOSTME-15

Device Description : Osteotome

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233761 Catalog Number : IMTRRHM-STD

Device Description : Rotating Hinge Metal-Cased Reamer: Standard

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233778 Catalog Number : IMTRRHM-SM

Device Description : Rotating Hinge Metal-Cased Reamer: Small

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233808 Catalog Number : IMTIBJIG-ROD

Device Description : Tibial Cutting Guide: Rod

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233815 Catalog Number : IMTIBJIG-RST

Device Description : Tibial Cutting Guide: Rest

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

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