SpineNet

FDA Regulatory Profile

SpineNet appears in FDA public data with 2 recalls, 2 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2103-2013, Class II) was initiated on February 5, 2013. Its most recent 510(k) clearance was granted on February 5, 2020.

Summary

Total Recalls
2
510(k) Clearances
2
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2103-2013Class IISpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical CFebruary 5, 2013
Z-2107-2013Class IISpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150February 4, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K200170SpineNet SSP SystemFebruary 5, 2020
K110733DAYTONA ANTERIOR CERVICAL CAGEAugust 25, 2011