FDA applicant
Ellipse Technologies, Inc.
FDA records 20 decisions for Ellipse Technologies, Inc. (Irvine, CA) from 2011 to 2016: 20 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and PGN (Growing Rod System- Magnetic Actuation). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 22 of them its own earlier devices. 5 recalls are linked to its devices.
FDA’s records also spell it “Ellipse Technologies, Incorporated”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ellipse Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2016
2026 so far, outlined.
Recalls per year
4in 2021
Class I Class II/III not classified
Planning a device like Ellipse Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Ellipse”
FDA records each applicant name separately; these may or may not be the same firm.