KWP · Class II · 21 CFR 888.3050

FDA Product Code KWP: Appliance, Fixation, Spinal Interlaminal

Leading manufacturers include Medtronic Sofamor Danek, Medtronic Sofamor Danek, Inc. and Synthes (Usa).

430
Total
430
Cleared
130d
Avg days
1978
Since

FDA 510(k) Cleared Appliance, Fixation, Spinal Interlaminal Devices (Product Code KWP)

430 devices
1–24 of 430
Cleared Jul 29, 2015
LnK Posterior Cervical Fixation System
K143278
L & K Biomed Co., Ltd.
Orthopedic · 257d
Cleared Jun 09, 2015
OASYS System
K150753
Stryker Corporation
Orthopedic · 78d
Cleared Apr 23, 2015
SOLSTICE OCT System
K142253
Life Spine, Inc.
Orthopedic · 252d
Cleared Apr 07, 2015
SOLSTICE OCT System
K143249
Life Spine, Inc.
Orthopedic · 146d
Cleared Apr 07, 2015
SOLSTICE OCT System
K150229
Life Spine, Inc.
Orthopedic · 64d
Cleared Jan 15, 2015
OASYS System
K142741
Stryker Corporation
Orthopedic · 113d
Cleared Sep 25, 2014
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
K141897
Synthes USA Products, LLC
Orthopedic · 73d
Cleared Jul 23, 2014
CASPIAN SPINAL SYSTEM
K141284
K2m, Inc.
Orthopedic · 68d
Cleared Jul 01, 2014
CASPIAN OCT SPINAL SYSTEM
K133288
K2m, Inc.
Orthopedic · 249d
Cleared Jun 02, 2014
VIRAGE OCT SPINAL FIXATION SYSTEM
K133556
Zimmer Spine, Inc.
Orthopedic · 195d
Cleared Jan 30, 2014
CENTURION POCT SYSTEM
K131833
Orthofix, Inc.
Orthopedic · 224d
Cleared Jan 16, 2014
SYNAPSE SYSTEM
K133698
Synthes USA Products, LLC
Orthopedic · 44d
Cleared Nov 25, 2013
TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
K132504
Corelink, LLC
Orthopedic · 105d
Cleared Oct 24, 2013
LOTUS
K131427
Spinal Elements, Inc.
Orthopedic · 160d
Cleared Aug 22, 2013
MOUNTAINEER OCT SPINAL SYSTEM
K132332
Medos International SARL
Orthopedic · 27d
Cleared Apr 01, 2013
VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
K123906
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 103d
Cleared Mar 14, 2013
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS
K123783
Globus Medical, Inc.
Orthopedic · 94d
Cleared Feb 25, 2013
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K123656
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 89d
Cleared Feb 12, 2013
GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
K121877
Exactech, Inc.
Orthopedic · 229d
Cleared Feb 07, 2013
SPINEOLOGY SPINOUS PROCESS PLATE
K123232
Spineology, Inc.
Orthopedic · 114d
Cleared Dec 18, 2012
VERTEX RECONSTRUCTION SYSTEM
K123568
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Oct 01, 2012
SOLSTICE CROSS CONNECTOR
K120998
Life Spine
Orthopedic · 182d
Cleared Jul 20, 2012
CASIAN, 3.5/4.5 CONNECTORS
K121808
K2m, Inc.
Orthopedic · 30d
Cleared Jul 18, 2012
M.U.S.T PEDICLE SCREW SYSTEM
K121115
Medacta International
Orthopedic · 97d

About Product Code KWP - Regulatory Context