MAGEC 2 Spinal Bracing and Distraction System

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K150885 ↗

FDA Product Code

PGN

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Ellipse Supplemental Instrument Trays

  Class II

  FDA 510(k) K151594 Active Cleared 25 Jan 2016

• PRECICE Intramedullary Limb Lengthening System

  Class II

  FDA 510(k) K150656 Active Cleared 23 Apr 2015

• PRECICE Trauma Nail System

  Class II

  FDA 510(k) K160267 Active Cleared 31 Mar 2016

• PRECISE Trauma Nail System

  Class II

  FDA 510(k) K142599 Active Cleared 16 Jan 2015

• PRECICE Intramedullary Limb Lengthening System Open recall

  Class II

  FDA 510(k) K151131 Active Cleared 19 Jun 2015

• PRECICE Trauma Nail System

  Class II

  FDA 510(k) K152370 Active Cleared 22 Dec 2015