Device product
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.
Z-2070-2015
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 71501
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 devices.
- Official record key
device-enforcement:Z-2070-2015
Official wording
Reason: Shipped to a single consignee prior to completion of final inspection.
Code information: Catalog Number 05-100-03-0042, Lot # 68122001.
Distribution pattern: Nationwide Distribution to Florida only.
Derived failure modes
-
Unknown
Shipped to a single consignee prior to completion of final inspection.