MNH · Class II · 21 CFR 888.3070

FDA Product Code MNH: Orthosis, Spondylolisthesis Spinal Fixation

Leading manufacturers include Acromed Corp., Depuyacromed and Medtronic Sofamor Danek, Inc..

309
Total
309
Cleared
127d
Avg days
1995
Since

FDA 510(k) Cleared Orthosis, Spondylolisthesis Spinal Fixation Devices (Product Code MNH)

309 devices
1–24 of 309
Cleared Dec 02, 2016
Reliance Spinal Screw System
K162066
Reliance Medical Systems, LLC
Orthopedic · 129d
Cleared Nov 03, 2016
CastleLoc Spinal Fixation System
K162801
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared Sep 23, 2016
FixxSure® X-Link
K162143
Innovasis, Inc.
Orthopedic · 53d
Cleared Sep 21, 2016
Spinal fixation system
K161151
Canwell Medical Co., Ltd.
Orthopedic · 149d
Cleared Aug 30, 2016
ANAX™ 5.5 Spinal System
K162189
U&I Corporation
Orthopedic · 26d
Cleared May 05, 2016
HC Spinal System
K151362
Hung Chun Bio-S Co., Ltd.
Orthopedic · 350d
Cleared Apr 21, 2016
Zavation Spinal System
K153404
Zavation, LLC
Orthopedic · 149d
Cleared Mar 02, 2016
Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
K160020
Captiva Spine
Orthopedic · 57d
Cleared Dec 11, 2015
Spinal Inner Fixation System
K143013
Changzhou Dingjian Medical Appliance Co., Ltd.
Orthopedic · 417d
Cleared Sep 10, 2015
Romeo posterior osteosynthesis system
K151695
Spineart
Orthopedic · 79d
Cleared Jun 26, 2015
CapLOX II/TowerLOX Pedicle Screw System
K151116
Captiva Spine
Orthopedic · 60d
Cleared Apr 29, 2015
Republic Spine Dark Star Spinal System
K150283
Republic Spine, LLC
Orthopedic · 83d
Cleared Mar 25, 2015
PASS LP Spinal System
K142798
Medicrea International SA
Orthopedic · 177d
Cleared Feb 25, 2015
ANAX 5.5 Spinal System
K143417
U&I Corporation
Orthopedic · 89d
Cleared Feb 12, 2015
PedFuse Pedicle Screw System
K143377
Spinefrontier, Inc.
Orthopedic · 79d
Cleared Jan 30, 2015
Ideal pedicle screw spinal system
K142957
Jiangsu Ideal Medical Science & Technology Co., Ltd.
Orthopedic · 108d
Cleared Jan 26, 2015
CB PROT II Posterior Spinal System
K142655
Chin Bone Technique Corp
Orthopedic · 130d
Cleared Jan 07, 2015
MAXIMIS SPINAL FIXATION SYSTEM
K140359
Valorem Surgical
Orthopedic · 329d
Cleared Nov 24, 2014
KangLi pedical screw spinal system
K142290
Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Orthopedic · 98d
Cleared Sep 03, 2014
GENERAL SPINAL SYSTEM
K134011
Changzhou Dean Medical Instrument Co, Ltd.
Orthopedic · 247d
Cleared Jun 30, 2014
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM
K133575
Spinevision S.A.
Orthopedic · 222d
Cleared Jun 26, 2014
KANGLI PEDICLE SCREW SPINAL SYSTEM
K140053
Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Orthopedic · 168d
Cleared Jun 26, 2014
INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
K141376
Nexxt Spine, LLC
Orthopedic · 30d
Cleared Jun 19, 2014
COSMOLOCK PEDICLE SCREW SYSTEM
K140678
Kalitec Direct, LLC
Orthopedic · 93d

About Product Code MNH - Regulatory Context