Atlas FDA

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

Cutting Edge Spine, LLC · Predicate Candidate Screening

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

102 daysmedian FDA review time
205 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC2025-03-12120
K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC2023-04-05230
K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC2022-06-241760
K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC2020-05-13280
K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC2020-04-02300
K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC2020-01-061170
K190025EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC2019-08-122170
K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC2018-06-251020
K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC2018-05-04290
K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC2015-07-131540
K102957CUTTING EDGE SPINE INTERBODY FUSION DEVICECutting Edge Spine, LLC2011-04-282050

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