Appliance, Fixation, Spinal Intervertebral Body
Innovasis, Inc.'s record for this product code
MDR events3All time
Recalls2All time
510(k) clearances3All time
Recent MDR events
3 adverse event reports on file
Recalls
2 recall events for this product code
- TerminatedMay 23, 2017
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
View FDA record ↗ - TerminatedUnknown
Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location labeled as "Fixed" should be labeled as "Variable" and the caddy location labeled as "Variable" should be labeled as "Fixed. If user installs a fixed rescue screw instead of variable, the screw head may not be flush, it could back out, which could interfere with the cover screw.
View FDA record ↗
510(k) clearances
3 clearances for this product code