Medical Device Manufacturer · US , Irvine , CA

Ellipse Technologies, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2011

Recent clearances: PRECICE Intramedullary Limb Lengthening System, MAGEC SPINAL BRACING AND DISTRACTION SYSTEM, RESIDUAL LIMB LENGTHENING SYSTEM

View 13 510(k) Devices ↓
13
Total
13
Cleared
0
Denied

FDA 510(k) Regulatory Record - Ellipse Technologies, Inc. Orthopedic ✕

13 devices
1-12 of 13
Cleared Apr 04, 2016
PRECICE Intramedullary Limb Lengthening System
K160325 · HSB
Orthopedic · 59d
Cleared Mar 24, 2015
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
K141278 · PGN
Orthopedic · 312d
Cleared Oct 07, 2014
RESIDUAL LIMB LENGTHENING SYSTEM
K141739 · HSB
Orthopedic · 102d
Cleared Sep 18, 2014
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
K140613 · PGN
Orthopedic · 192d
Cleared Jun 30, 2014
PRECICE TRAUMA NAIL SYSTEM
K141447 · HSB
Orthopedic · 28d
Cleared May 20, 2014
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K141023 · HSB
Orthopedic · 29d
Cleared Feb 27, 2014
ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
K140178 · PGN
Orthopedic · 34d
Cleared Jan 23, 2014
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K131490 · HSB
Orthopedic · 245d
Cleared Dec 09, 2013
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K133289 · HSB
Orthopedic · 45d
Cleared Oct 11, 2013
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K131677 · HSB
Orthopedic · 123d
Cleared Oct 19, 2012
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K113219 · HSB
Orthopedic · 353d
Cleared Mar 28, 2012
ELLIPSE PRECICE TRAUMA NAIL SYSTEM
K113695 · HSB
Orthopedic · 103d
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