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 - 05060296234409 Catalog Number : TMKTP-SM5R

Device Description : Trial Tibial Plateau Plate: 5mm Small

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296234416 Catalog Number : TMKTP-SM10R

Device Description : Trial Tibial Plateau Plate: 10mm Small

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296234423 Catalog Number : TMKTP-SM15R

Device Description : Trial Tibial Plateau Plate: 15mm Small

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296234430 Catalog Number : TMKTP-SM20R

Device Description : Trial Tibial Plateau Plate: 20mm Small

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Stanmore - 05060296235970 Catalog Number : SMMLTBC00

Device Description : Tibial Rotating Hinge Metal Cased Bearing XSM

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296236007 Catalog Number : JTS-DRIVE-UNIT

Device Description : JTS Drive Unit Set

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Stanmore - 05060296236052 Catalog Number : JTSDF-R-XSM

Device Description : JTS Distal Femur Right XSM

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Stanmore - 05060296236069 Catalog Number : JTSDF-R-SM

Device Description : JTS Distal Femur Right SM

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Stanmore - 05060296236076 Catalog Number : JTSDF-R-STD

Device Description : JTS Distal Femur Right STD

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Stanmore - 05060296236083 Catalog Number : JTSDF-L-XSM

Device Description : JTS Distal Femur Left XSM

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

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