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 Jun 04, 2015
Sure Lok Mini Posterior Cervical/Upper Thoracic System
K150851
Precision Spine, Inc.
Orthopedic · 65d
Cleared Apr 29, 2015
Reliance Posterior Cervical-Thoracic System
K142867
Reliance Medical Systems, LLC
Orthopedic · 210d
Cleared Apr 28, 2015
Streamline OCT Occipito-Cervico-Thoracic System
K150254
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Orthopedic · 84d
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 Dec 22, 2014
Caspian OCT/MESA Mini/DENALI Mini Spinal System
K142558
K2m
Orthopedic · 102d
Cleared Dec 15, 2014
NEXTGEN ALTIUS OCT SYSTEM
K140734
Ebi, LLC
Orthopedic · 266d
Cleared Oct 01, 2014
EXPEDIUM Spine System/Synapse System
K142460
Johnson and Johnson
Orthopedic · 29d
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 Apr 11, 2014
GIBRALT ROD-TO-ROD CROSS CONNECTORS
K140645
Exactech Sarasota
Orthopedic · 29d
Cleared Mar 19, 2014
STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
K133374
Pioneer Surgical Technology, Inc. (Rti Surgical, I
Orthopedic · 138d
Cleared Mar 07, 2014
BLACKBIRD SPINAL SYSTEM
K133214
Choicespine, LP
Orthopedic · 140d
Cleared Jan 30, 2014
CENTURION POCT SYSTEM
K131833
Orthofix, Inc.
Orthopedic · 224d
Cleared Jan 22, 2014
KESTREL POSTERIOR CERVICAL SPINE SYSTEM
K132122
Omni Surgical, LLC Dba Spine360
Orthopedic · 196d
Cleared Jan 16, 2014
SYNAPSE SYSTEM
K133698
Synthes USA Products, LLC
Orthopedic · 44d
Cleared Dec 11, 2013
CERTEX OCT SPINAL IMPLANT SYSTEM
K133094
X-Spine Systems, Inc.
Orthopedic · 72d
Cleared Nov 25, 2013
TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
K132504
Corelink, LLC
Orthopedic · 105d

About Product Code KWP - Regulatory Context