MNI · Class II · 21 CFR 888.3070

FDA Product Code MNI: Orthosis, Spinal Pedicle Fixation

Leading manufacturers include K2m, Inc., Medtronic Sofamor Danek, Inc. and Spine Wave, Inc..

303
Total
303
Cleared
95d
Avg days
1998
Since

FDA 510(k) Cleared Orthosis, Spinal Pedicle Fixation Devices (Product Code MNI)

303 devices
1–24 of 303
Cleared Oct 12, 2017
Mikron Spinal Fixation System
K171497
Mikron Makina Sanayi Ticaret Co. , Ltd.
Orthopedic · 143d
Cleared Oct 04, 2016
LumFix Spinal Fixation Sytem
K160731
CG Bio Co., Ltd.
Orthopedic · 201d
Cleared Aug 22, 2016
Double Medical Universal Spine System
K151458
Double Medical Technology, Inc.
Orthopedic · 448d
Cleared Jun 29, 2016
MySpine Pedicle Screw Placement Guides - LP
K153273
Medacta International S.A.
Orthopedic · 230d
Cleared Apr 04, 2016
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
K160124
Spinevision S.A.
Orthopedic · 75d
Cleared Apr 01, 2016
Premier
K160320
Shandong Weigao Orthopaedic Device Co., Ltd.
Orthopedic · 56d
Cleared Feb 26, 2016
Sniper (R) Spine System
K160003
Spine Wave, Inc.
Orthopedic · 53d
Cleared Feb 01, 2016
YAHUA Spinal System
K152324
Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.
Orthopedic · 168d
Cleared Dec 11, 2015
FIREFLY Pedicle Screw Navigation Guide
K143222
Mighty Oak Medical, Inc.
Orthopedic · 396d
Cleared Nov 18, 2015
WASTON General Spinal System
K150684
Changzhou Waston Medical Appliance Co., Ltd.
Orthopedic · 246d
Cleared Sep 25, 2015
X-spine Pedicle Screw System
K152132
X-Spine Systems, Inc.
Orthopedic · 56d
Cleared Sep 24, 2015
Gemmed pedicle screw spinal system
K151592
Suzhou Gemmed Medical Instrument Co., Ltd.
Orthopedic · 104d
Cleared Sep 17, 2015
ODALYS Pedicle Screw System
K152098
Kisco International
Orthopedic · 51d
Cleared Sep 17, 2015
Reliance Spinal Screw System
K152131
Reliance Medical Systems, LLC
Orthopedic · 48d
Cleared Aug 31, 2015
Sniper Spine System
K152174
Spine Wave, Inc.
Orthopedic · 27d
Cleared Jul 31, 2015
Sniper Spine System
K151813
Spine Wave, Inc.
Orthopedic · 29d
Cleared Jun 05, 2015
DPZ Pedicular Fixation System
K150294
Osteomed Implantes, Ltda
Orthopedic · 119d
Cleared Apr 08, 2015
Polyscrew Pedicle Screw System
K150647
New Era Orthopedics, LLC
Orthopedic · 27d
Cleared Feb 10, 2015
PASS LP Spinal System
K150049
Medicrea International
Orthopedic · 29d
Cleared Jan 09, 2015
NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
K141253
New Era Orthopaedics, LLC
Orthopedic · 240d
Cleared Nov 04, 2014
PASS LP SPINAL SYSTEM
K140738
Medicrea International
Orthopedic · 224d
Cleared Sep 10, 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS
K141835
Spineart
Orthopedic · 65d
Cleared Jun 26, 2014
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
K141397
Precision Spine, Inc.
Orthopedic · 29d
Cleared May 23, 2014
MYSPINE PEDICLE SCREW PLACEMENT GUIDES
K132788
Medacta International
Orthopedic · 259d

About Product Code MNI - Regulatory Context