FDA-Device2014-08-13Class II
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
X Spine Systems Inc
Hazard
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
Sold states
US Distribution including the states of FL and MO.
Affected count
A total of 5-pieces of each part number distributed
Manufactured in
452 Alexandersville Rd, N/A, Miamisburg, OH, United States
Products
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2136-2014Don't want to check this manually?
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