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II. SPECIFIC PRODUCT INFORMATION
A. SALVATION
™
MIDFOOT RECONSTRUCTION SYSTEM
DESCRIPTION
The SALVATION
™
Midfoot Reconstruction System, which is comprised of Bolts, Beams,
and Nails, was designed to address the demands of advanced midfoot reconstruction.
The 5.0mm Fusion Bolt and 6.5mm Fusion Bolt feature a solid core design. The 7.0
Fusion Beam features a cannulated design to facilitate placing the implant over a K-Wire.
The 8.0mm Nail features a compression slot for internal compression with a cross screw
for rotational stability. All implants are made from Ti6Al4V (titanium alloy).
INDICATIONS
The SALVATION
™
Midfoot Reconstruction System is indicated for fracture fixation,
osteotomies, reconstruction procedures, non-unions, and fusions of bones in the foot
and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus;
specific examples include: intramedullary medial column fusion and lateral column fusion
resulting from neuropathic osteoarthropathy (Charcot).
CAUTION: Federal Law (U.S.) restricts this device to sale or use by or on the order of a
physician. ™ and ® denote Trademarks and Registered Trademarks of Wright Medical Group
N.V. or its affiliates.
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