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) (8) Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

No Yes

Clear

Stanmore - 05060296236090 Catalog Number : JTSDF-L-SM

Device Description : JTS Distal Femur Left SM

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Stanmore - 05060296236106 Catalog Number : JTSDF-L-STD

Device Description : JTS Distal Femur Left STD

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296236113 Catalog Number : JTS-ALGNMT

Device Description : Alignment Tool 50, 70, & 90mm

Device Class : 1

Duns Number: 494989502

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Instrument - 05060296236120 Catalog Number : JTS-FACE

Device Description : Face Cutter Body & Spigot

Device Class : 1

Duns Number: 494989502

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Instrument - 05060296236137 Catalog Number : IMBC-EXSM

Device Description : Bush Compressor: Extra-Small

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296236151 Catalog Number : IMTRRHM-EXSM

Device Description : Rotating Hinge Metal-Cased Reamer: Extra-Small

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296236168 Catalog Number : PIN

Device Description : Cutting Guide Fixation Pin

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296236175 Catalog Number : IMTRRHP-EXSM

Device Description : Rotating Hinge Polyethylene Reamer: Extra-Small

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296236182 Catalog Number : IMPBIMP-EXSM

Device Description : Plastic Tibial Bearing Impactor: Extra-Small

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

Instrument - 05060296236199 Catalog Number : TMKTP-EXSM5

Device Description : Trial Tibial Plateau Plate: 5mm Extra-Small

Device Class : 2

Duns Number: 494989502

Premarket Exempt : No

Product Code : KRO

Prescription Use : Yes

Device Count : 1

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