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
430 devices
25–48 of 430
Cleared Oct 25, 2013
MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM
K132900
Intelligent Implant Systems, LLC
Orthopedic · 39d
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 May 24, 2013
LANX SPINAL FIXATION SYSTEM
K131156
Lanx, Inc.
Orthopedic · 30d
Cleared Apr 01, 2013
VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
K123906
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 103d
Cleared Mar 21, 2013
PASS OCT SPINAL SYSTEM
K121979
Medicrea International
Orthopedic · 258d
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 20, 2012
STABILINK MIS SPINAL FIXATION SYSTEM
K123093
Southern Spine, LLC
Orthopedic · 79d
Cleared Dec 18, 2012
VERTEX RECONSTRUCTION SYSTEM
K123568
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Dec 17, 2012
VERTIFLEX SPINOUS PROCESS FIXATION PLATE
K122509
Vertiflex, Inc.
Orthopedic · 122d
Cleared Nov 07, 2012
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
K121725
Pioneer Surgical Technology, Inc.
Orthopedic · 148d
Cleared Oct 24, 2012
RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
K122292
Reliance Medical Systems, LLC
Orthopedic · 85d
Cleared Oct 01, 2012
SOLSTICE CROSS CONNECTOR
K120998
Life Spine
Orthopedic · 182d
Cleared Sep 20, 2012
NEXTGEN ALTIUS OCT SYSTEM
K122378
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 45d
Cleared Aug 09, 2012
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
K121136
Accel Spine
Orthopedic · 118d
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
Cleared Jun 29, 2012
VERTEX RCCONSTRUCTION SYSTEM
K121191
Medtronic Sofamor Danek, Inc.
Orthopedic · 71d
Cleared Apr 17, 2012
NEXTGEN ALTIUS OCT SYSTEM
K113593
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 134d
Cleared Mar 28, 2012
REXIOUS HOOK FIXATION SYSTEMS
K113324
Dio Medical Co., Ltd.
Orthopedic · 139d
Cleared Mar 12, 2012
PIONEER POSTERIOR CERVICO THORACIC SYSTEM
K112757
Pioneer Surgical Technology, Inc.
Orthopedic · 172d