510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150885Substantially Equivalent

MAGEC 2 Spinal Bracing and Distraction System

Ellipse Technologies, Incorporated, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150885 is the FDA 510(k) clearance record for MAGEC 2 Spinal Bracing and Distraction System, a class II device, cleared for Ellipse Technologies, Incorporated on under FDA product code PGN (Growing Rod System- Magnetic Actuation). FDA's definition for product code PGN reads: "Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod". FDA records list 7 510(k) clearances for Ellipse Technologies, Incorporated, from to . As of , FDA records show no recalls naming K150885.

Clearance record

Decision date
Received
(57 days to decision)
Product code
PGN Growing Rod System- Magnetic Actuation
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Ellipse Technologies, Incorporated 13900 Alton Pkwy. Suite 123, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PGN

Trailing 12 months

FDA records hold no clearances under product code PGN in the trailing twelve months.

FDA records show no clearances under product code PGN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PGN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260