Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Camber Spine Technologies, LLC — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

197 daysmedian FDA review time
641 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC2024-04-162630
K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC2022-09-026410
K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Camber Spine Technologies, LLC2021-06-151060
K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC2019-10-221300
K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS PosterCamber Spine Technologies, LLC2018-10-271970
K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC2018-06-25970

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda