FDA-Device2015-07-22Class II
Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration 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, pseudoarthrosis, and failed previou
Exactech, Inc.
Hazard
Shipped to a single consignee prior to completion of final inspection.
Sold states
Nationwide Distribution to Florida only.
Affected count
4 devices.
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration 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, pseudoarthrosis, and failed previous fusion.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2070-2015Don't want to check this manually?
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