Product code KWP— Orthopedic
CD HORIZON SPINAL SYSTEM
- Classification name
- Appliance, Fixation, Spinal Interlaminal
- Device class
- Class 2
- Regulation
- 21 CFR 888.3050
- Advisory panel
- Orthopedic
- Total cleared
- 430
- First cleared
- Most recent
Market context for product code KWP
FDA has cleared devices under product code KWP between 1978 and 2015, filed by 142 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
Top applicants under product code KWP
Adverse events under product code KWP
product code KWP- Death
- 7
- Injury
- 1,539
- Malfunction
- 1,519
- Total
- 3,065
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KWP
1–100 of 430- K143278 — LnK Posterior Cervical Fixation System
- K150753 — OASYS System
- K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System
- K142867 — Reliance Posterior Cervical-Thoracic System
- K150254 — Streamline OCT Occipito-Cervico-Thoracic System
- K142253 — SOLSTICE OCT System
- K143249 — SOLSTICE OCT System
- K150229 — SOLSTICE OCT System
- K142741 — OASYS System
- K142558 — Caspian OCT/MESA Mini/DENALI Mini Spinal System
- K140734 — NEXTGEN ALTIUS OCT SYSTEM
- K142460 — EXPEDIUM Spine System/Synapse System
- K141897 — SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
- K141284 — CASPIAN SPINAL SYSTEM
- K133288 — CASPIAN OCT SPINAL SYSTEM
- K133556 — VIRAGE OCT SPINAL FIXATION SYSTEM
- K140645 — GIBRALT ROD-TO-ROD CROSS CONNECTORS
- K133374 — STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
- K133214 — BLACKBIRD SPINAL SYSTEM
- K131833 — CENTURION POCT SYSTEM
- K132122 — KESTREL POSTERIOR CERVICAL SPINE SYSTEM
- K133698 — SYNAPSE SYSTEM
- K133094 — CERTEX OCT SPINAL IMPLANT SYSTEM
- K132504 — TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
- K132900 — MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM
- K131427 — LOTUS
- K132332 — MOUNTAINEER OCT SPINAL SYSTEM
- K131156 — LANX SPINAL FIXATION SYSTEM
- K123906 — VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
- K121979 — PASS OCT SPINAL SYSTEM
- K123783 — ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS
- K123656 — VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
- K121877 — GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
- K123232 — SPINEOLOGY SPINOUS PROCESS PLATE
- K123093 — STABILINK MIS SPINAL FIXATION SYSTEM
- K123568 — VERTEX RECONSTRUCTION SYSTEM
- K122509 — VERTIFLEX SPINOUS PROCESS FIXATION PLATE
- K121725 — PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
- K122292 — RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
- K120998 — SOLSTICE CROSS CONNECTOR
- K122378 — NEXTGEN ALTIUS OCT SYSTEM
- K121136 — RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
- K121808 — CASIAN, 3.5/4.5 CONNECTORS
- K121115 — M.U.S.T PEDICLE SCREW SYSTEM
- K121191 — VERTEX RCCONSTRUCTION SYSTEM
- K113593 — NEXTGEN ALTIUS OCT SYSTEM
- K113324 — REXIOUS HOOK FIXATION SYSTEMS
- K112757 — PIONEER POSTERIOR CERVICO THORACIC SYSTEM
- K113346 — NEON SYSTEM
- K112595 — COFLEX-F
- K111719 — OASYS SPINAL SYSTEM
- K113654 — CASPIAN
- K112592 — AXLE PEEK INTERSPINOUS FUSION SYSTEM
- K112025 — SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
- K103205 — BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM
- K111183 — ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)
- K110963 — ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
- K103091 — LANX SPINAL FIXATION SYSTEM
- K110353 — MOUNTAINEER OCT SPINAL SYSTEM
- K110522 — VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
- K110367 — PIONEER SPINAL PROCESS FUSION PLATE
- K102886 — CD HORIZON SPINAL SYSTEM
- K102195 — SP-FIX SPINOUS PROCESS FIXATION PLATE
- K103232 — CASPIAN SPINAL SYSTEM
- K101471 — AXLE INTERSPINOUS FUSION SYSTEM
- K100888 — MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
- K101183 — MODIFICATION TO: OASYS SYSTEM
- K101112 — RELIANCE SPINAL SCREW SYSTEM
- K101525 — PIONEER SPINOUS PROCESS FUSION PLATE
- K093438 — PARADIGM INTERSPINOUS FUSION PLATE
- K101084 — CASPIAN SPINAL SYSTEM
- K102020 — VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
- K100354 — PRIMAL OK INTERSPINOUS FUSION SYSTEM
- K093319 — NUVASIVE VUEPOINT OCT SYSTEM
- K100685 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K100191 — LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
- K092825 — APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER
- K092295 — PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
- K093534 — MODIFICATION TO CASPIAN SPINAL SYSTEM
- K092656 — LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
- K091359 — GSO PCT SPINAL SYSTEM
- K090343 — SENTINEL SPINAL SYSTEM
- K091365 — VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
- K091689 — SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
- K090565 — ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
- K090060 — NEXLINK OCT SYSTEM, MODEL 7000 SERIES
- K090549 — SYNTHES SYNAPSE TRANSCONNECTOR
- K090714 — VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
- K090252 — MODIFICATION TO: LANX SPINAL FIXATION SYSTEM
- K082728 — VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
- K082769 — MESA AND RANGE SPINAL SYSTEMS
- K081906 — PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
- K083071 — VERTEX RECONSTRUCTION SYSTEM
- K081107 — CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
- K081297 — VERTEX RECONSTRUCTION SYSTEM
- K080790 — MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM
- K080805 — MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
- K072729 — SIERRA
- K080526 — SIERRA SYSTEM
- K073278 — SPINOUS PROCESS PLATE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.