Stanmore Implants Worldwide Ltd.

Device Identifier: PIN 19960, Lot: 19960

Orthopedic Devices

2

Yes

US distribution to OH.

Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960

B10586, B11126, B9875, B9946, B10751, B11513, B9874, B10602, B9876

Orthopedic Devices

2

Yes

Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone

B10635, B11820, B12776, B10636, B10638, B9866

Orthopedic Devices

2

Yes

Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone

B10191, B10443, B9920, B10561, B9921, B9922

Orthopedic Devices

2

Yes

Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone

A10337, A11525, A7823, A9990, A11289, A11979, A12134, A7186, A8679, A9743, A10344, A10629, A10791, A10348a, A11198, A11557, A11895, A12090, A12129, A12220, A12223, A12229

Orthopedic Devices

2

Yes

Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone