Medical Device Manufacturer · US , Santa Fe Springs , CA

Medyssey Co, Ltd. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2009

Recent clearances: NeckTune™ SA Cervical Cage, NeckTune™ 3D SA Cervical Cage, Medyssey Navigation System

13
Total
13
Cleared
0
Denied

FDA 510(k) Regulatory Record - Medyssey Co, Ltd. Orthopedic ✕

13 devices
1-13 of 13
Cleared Sep 29, 2026
NeckTune™ SA Cervical Cage
K262726 · OVE
Orthopedic · 60d
Cleared Jun 15, 2026
NeckTune™ 3D SA Cervical Cage
K260036 · OVE
Orthopedic · 160d
Cleared Apr 16, 2025
Medyssey Navigation System
K242806 · OLO
Orthopedic · 211d
Cleared Jan 25, 2013
MEDYSSEY CANNULATED PEDICLE SCREW
K121670 · NKB
Orthopedic · 233d
Cleared Aug 10, 2012
C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE
K121320 · ODP
Orthopedic · 100d
Cleared Jun 15, 2012
MEDYSSY LT CAGE SYSTEM
K121246 · MAX
Orthopedic · 51d
Cleared Jun 08, 2011
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
K110284 · MNI
Orthopedic · 127d
Cleared May 19, 2011
ZENIUS SPINAL SYSTEM
K110283 · MNI
Orthopedic · 107d
Cleared Apr 08, 2011
LP CAGE
K110067 · MAX
Orthopedic · 88d
Cleared Dec 29, 2010
ZENIUS SPINAL SYSTEM
K103272 · MNI
Orthopedic · 54d
Cleared Dec 16, 2010
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
K103147 · MNI
Orthopedic · 52d
Cleared Jun 25, 2010
MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM
K093104 · MNI
Orthopedic · 267d
Cleared Jan 30, 2009
NOVEL SPINAL SYSTEM
K081153 · MNH
Orthopedic · 282d
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