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

Stanmore - 05060296232849 Catalog Number : SMLTBC00

Device Description : Tibial Rotating Hinge Poly Cased Bearing XSM

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Stanmore - 05060296233136 Catalog Number : SMCAP01

Device Description : Axle Cap

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Stanmore - 05060296233150 Catalog Number : SMBSH00

Device Description : Bushes XSM

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Stanmore - 05060296233167 Catalog Number : SMBPR00

Device Description : Bumper Pad XSM

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233570 Catalog Number : IMARDRL

Device Description : AR Lug Drill

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233587 Catalog Number : IMBC-SM

Device Description : Bush Compressor: Small

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233600 Catalog Number : IMBC-NUT

Device Description : Compressor Nut

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233617 Catalog Number : IMBC-STD

Device Description : Bush Compressor: Standard

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233631 Catalog Number : IMHAM

Device Description : Hammer

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296233693 Catalog Number : IMCIRPR

Device Description : Circlip Pliers

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

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