Arsenal Spinal Fixation System

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Orthopedic Devices

2

Yes

Worldwide Distribution - US Nationwide in the states of (TX, AL, UT, FL, IA, SD, NV, OH, CA, MN, CO, AZ, OK, MI, VA, KY, and Puerto Rico) and country of Japan

Arsenal Spinal Fixation System, Set Screw, Part No. 47027 || Product Usage: || The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo).

Lot Numbers 695621  696252  697128  698437  700943  7689801 695622  696253  697129  698438  700944  7689802 695623  696254  697130  698439  700945  7689803 695624  696255  697131  698440  701393  7689804 695625  696256  697520  698441  701394  695626  696257  697521  698442  701395  695627  696258  697522  700611  701396  696124  696558  697523  700612  701397  696125  696574  697524  700613  701398 696126  696575  698433  700614  701399 696127  696576  698434  700615  701400 696128  696577  698435  700941  701401 696251  697127  698436  700942  701851 7878901 7829602 7766302 7766301

Orthopedic Devices

2

Yes

Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain.

Arsenal Spinal Fixation System, Set Screw, Part No. 47127 || Product Usage: Usage: || The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).

Arsenal Set-Screw, a sub-component of the Arsenal Spinal Fixation SystemPart Number: 47127Lot Numbers affectedFor screw back-out issue:700942For oversized condition: 7689802, 7689803, 7766301ARTG Number: 178654