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
303 devices
25–48 of 303
Cleared Apr 29, 2014
GENERAL SPINAL SYSTEM
K140229
Tianjin Walkman Biomaterial Co., Ltd.
Orthopedic · 89d
Cleared Jan 27, 2014
AVERSION PEDICLE SCREW SYSTEM
K133103
K7, LLC
Orthopedic · 119d
Cleared Dec 16, 2013
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS
K130073
Mikron Makina Sanayi VE Ticaret Ltd. Sti.
Orthopedic · 339d
Cleared Nov 20, 2013
EVEREST SPINAL SYSTEM
K132757
K2m, Inc.
Orthopedic · 77d
Cleared Oct 31, 2013
ALTUS SPINE PEDICLE SCREW SYSTEM
K132280
Altus Partners
Orthopedic · 100d
Cleared Oct 17, 2013
TRUE SPINAL FIXATION SYSTEM
K130958
Innovative Surgical Designs
Orthopedic · 195d
Cleared Oct 10, 2013
INERTIA MIS PEDICLE SCREW SYSTEM
K132412
Nexxt Spine, LLC
Orthopedic · 69d
Cleared Oct 03, 2013
EVEREST SPINAL SYSTEM
K132361
K2m, Inc.
Orthopedic · 65d
Cleared Sep 19, 2013
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
K132644
Corentec Co., Ltd.
Orthopedic · 24d
Cleared Aug 20, 2013
SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
K132365
Accel Spine
Orthopedic · 21d
Cleared Aug 09, 2013
CORE PEDICLE SCREW SYSTEM
K131522
Core-Nexus
Orthopedic · 73d
Cleared Aug 09, 2013
CAPSURE PS SYSTEM
K132154
Spine Wave, Inc.
Orthopedic · 28d
Cleared Jul 30, 2013
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT
K130302
Spinevision S.A.
Orthopedic · 173d
Cleared Jul 24, 2013
REFORM PEDICLE SCREW SYSTEM
K131343
Spinal USA
Orthopedic · 76d
Cleared Jun 20, 2013
REFORM PEDICLE SCREW SYSTEM
K130279
Spinal USA
Orthopedic · 135d
Cleared Feb 07, 2013
RELIANCE SPINAL SCREW SYSTEM
K123521
Reliance Medical Systems, LLC
Orthopedic · 84d
Cleared Nov 20, 2012
S-LOK PSS SYSTEM
K122931
Spinal USA
Orthopedic · 57d
Cleared Oct 31, 2012
CERTEX SPINAL IMPLANT SYSTEM
K122163
X-Spine Systems, Inc.
Orthopedic · 103d
Cleared Oct 16, 2012
TOWERLOX PEDICLE SCREW SYSTEM
K122332
Captiva Spine
Orthopedic · 75d
Cleared Oct 11, 2012
CAPSURE(R) PS SYSTEM
K122233
Spine Wave, Inc.
Orthopedic · 77d
Cleared Aug 15, 2012
4CIS VANE SPINE SYSTEM
K121615
Solco Biomedical Co., Ltd.
Orthopedic · 75d
Cleared Aug 08, 2012
REFORM PEDICLE SCREW SYSTEM
K121172
Spinal USA
Orthopedic · 113d
Cleared Jun 07, 2012
CAPSURE(R) PS SYSTEM
K120646
Spine Wave, Inc.
Orthopedic · 97d
Cleared May 25, 2012
RANGE SPINAL SYSTEM, UNIT ROD
K120899
K2m, Inc.
Orthopedic · 60d