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Camber Spine Technologies

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K234077SPIRA® Anterior Lumbar SpacersJuly 12, 2024
K232256Alcantara Thoracolumbar Plate SystemApril 16, 2024
K233972Camber Sacroiliac (SI) Fixation SystemFebruary 27, 2024
K230942SPIRA® Posterior Lumbar SpacersJuly 11, 2023
K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)March 30, 2023
K223837SPIRA®-C Integrated Fixation SystemMarch 22, 2023
K203503Camber Sacroiliac (SI) Fixation SystemSeptember 2, 2022
K220038Camber Spine Navigation SystemApril 29, 2022
K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersJune 15, 2021
K193153SPIRA-C Integrated Fixation SystemApril 24, 2020
K191584FORTICO Anterior Cervical Fixation SystemOctober 22, 2019
K190483SPIRA Open Matrix ALIF and LLIFSeptember 23, 2019
K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemOctober 27, 2018
K180724SPIRA Open Matrix LLIFJune 25, 2018
K173432ENZA-A Titanium ALIFApril 18, 2018
K173800Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy CageFebruary 2, 2018
K172446SPIRA-C Open Matrix Cervical InterbodyNovember 7, 2017
K172064Ti-Diagon Oblique TLIFSeptember 15, 2017
K170550Coveris Cervical Cage SystemJuly 13, 2017
K162986SPIRA Open Matrix ALIFJune 12, 2017