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Spinecraft, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260015ANTERIS Thoracolumbar Plate SystemMarch 4, 2026
K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemJuly 20, 2023
K223273ASTRA Spine SystemDecember 22, 2022
K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSeptember 30, 2021
K211323ASTRA Spine SystemJune 3, 2021
K181350ASTRA-OCT Spine SystemJuly 6, 2018
K143683APEX-DL Spine SystemMay 22, 2015
K150417ASTRA SPINE SYSTEMMay 19, 2015
K131521VELOX ANTERIOR CERVICAL PLATE SYSTEMDecember 24, 2013
K132603APEX SPINE SYSTEMNovember 20, 2013
K110906APEX SPINE SYSTEMJuly 26, 2011
K103505ALTUM ANTERIOR CERVICAL PLATEMarch 15, 2011
K102488APEX SPINE SYSTEM W/ COCR RODSDecember 10, 2010
K092825APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHERMarch 16, 2010
K090887ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGESOctober 30, 2009
K062513APEX SPINE SYSTEMDecember 22, 2006
K062496OSTEOPORE TCPOctober 19, 2006