Atlas FDA

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

Republic Spine, LLC — Predicate Candidate Screening

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

90 daysmedian FDA review time
280 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC2023-05-262380
K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC2021-09-27900
K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC2021-03-052800
K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC2019-09-122050
K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC2019-06-19750
K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC2018-07-25490
K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC2015-04-29830

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