Atlas FDA

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

Choice Spine, LLC — Predicate Candidate Screening

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

165 daysmedian FDA review time
265 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC2023-09-142650
K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC2022-09-131650
K220024ChoiceSpine Navigation SystemChoice Spine, LLC2022-07-061820
K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC2021-08-311130
K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC2021-05-101810
K203561ChoiceSpine Navigation SystemChoice Spine, LLC2021-01-04280
K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC2020-12-221880
K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Choice Spine, LLC2019-08-15580
K191367Harrier-SA Lumbar Interbody SystemChoice Spine, LLC2019-07-05440

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