FDA-Device2021-03-17Class II
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Hazard
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Sold states
US Nationwide distribution.
Manufactured in
375 River Park Cir, Marquette, MI, United States
Products
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1226-2021Don't want to check this manually?
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