Synthes USA HQ, Inc.

J5606-C

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) Canada and Mexico

Synthes TomoFix Plates || The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.

part 219.951 with multiple lot#:   2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841

Orthopedic Devices

2

Yes

Nationwide Distribution

Synthes Spiked Washers 13.5/6.5 || Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

all lots of part no. 03.802.039

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and Internationally to Canada .

Synthes Implant Holder for Synfix (TM)-LR || the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery

part nos. 456.300-456.310 & 456.650, 456.300S-456.310S & 456.650S, with lot nos. 5615864 through 7423581

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada.

Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade || Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.

part no. 396.396 (lot nos. T989765 and T989780), part no. 03.632.087 (lotT987270), part no. 03.812.005 (lot nos. T987734, T988931, and T987623), and part no. 03.820.129 (lot no. T988206).

Orthopedic Devices

1

No

Worldwided Distribution: USA (nationwide) including IL, MO, TX, WA and Internationally to Canada and Switzerland.

Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) || Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.