Atlas FDA

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

PGN · Predicate Candidate Screening

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

76 daysmedian FDA review time
312 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K233593MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated2024-02-06900
K201543MAGEC® SystemNuvasive Specialized Orthopedics, Inc.2020-07-30511
K171791MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated2017-08-31761
K160352MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc.2016-10-212560
K161751MAGEC® Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Inc.2016-09-02700
K150885MAGEC 2 Spinal Bracing and Distraction SystemEllipse Technologies, Incorporated2015-05-29570
K141278MAGEC SPINAL BRACING AND DISTRACTION SYSTEMEllipse Technologies, Inc.2015-03-243120
K140613MAGEC SPINAL BRACING AND DISTRACTION SYSTEMEllipse Technologies, Inc.2014-09-181920
K140178ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEMEllipse Technologies, Inc.2014-02-27340

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