Product code MNH— Orthopedic
CD HORIZON SPINAL SYSTEM
- Classification name
- Orthosis, Spondylolisthesis Spinal Fixation
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Total cleared
- 309
- First cleared
- Most recent
Market context for product code MNH
FDA has cleared devices under product code MNH between 1995 and 2016, filed by 145 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- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
Top applicants under product code MNH
Adverse events under product code MNH
product code MNH- Injury
- 978
- Malfunction
- 793
- Total
- 1,771
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 MNH
1–100 of 309- K162066 — Reliance Spinal Screw System
- K162801 — CastleLoc Spinal Fixation System
- K162143 — FixxSure® X-Link
- K161151 — Spinal fixation system
- K162189 — ANAX 5.5 Spinal System
- K151362 — HC Spinal System
- K153404 — Zavation Spinal System
- K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
- K143013 — Spinal Inner Fixation System
- K151695 — Romeo posterior osteosynthesis system
- K151116 — CapLOX II/TowerLOX Pedicle Screw System
- K150283 — Republic Spine Dark Star Spinal System
- K142798 — PASS LP Spinal System
- K143417 — ANAX 5.5 Spinal System
- K143377 — PedFuse Pedicle Screw System
- K142957 — Ideal pedicle screw spinal system
- K142655 — CB PROT II Posterior Spinal System
- K140359 — MAXIMIS SPINAL FIXATION SYSTEM
- K142290 — KangLi pedical screw spinal system
- K134011 — GENERAL SPINAL SYSTEM
- K133575 — SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM
- K140053 — KANGLI PEDICLE SCREW SPINAL SYSTEM
- K141376 — INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
- K140678 — COSMOLOCK PEDICLE SCREW SYSTEM
- K140787 — PLS (POSTERIOR LUMBAR SYSTEM)
- K140948 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K133153 — SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
- K133690 — TRUE SPINAL FUSSION SYSTEM
- K133287 — PRESSON SPINAL FIXATION SYSTEM
- K132403 — ANNEXTM ADJACENT LEVEL SYSTEM
- K132218 — PERFIX ILIAC SCREW SYSTEM
- K132101 — ANAX 5.5 SPINAL SYSTEM
- K131538 — CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM
- K131810 — OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM
- K130267 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K122994 — INTRAMEDULLARY NAIL SYSTEM
- K123487 — GSO GS1 CANNULATED SCREW SYSTEM
- K123164 — SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
- K123476 — MEGA 5.5 SPINE SYSTEM
- K122592 — INSTINCT JAVA SYSTEM
- K122814 — GALLEON PEDICLE SCREW SYSTEM
- K120832 — FORTEX PEDICLE SCREW SYSTEM
- K120760 — LDR SPINE SPINETUNE TL SPINAL SYSTEM
- K121016 — RANGE SPINAL SYSTEM (MESA AND DENALI)
- K111940 — S 100 PEDICLE SCREW SYSTEM
- K120353 — SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
- K120491 — DSS STABILIZATION SYSTEM-RIGID
- K103573 — ARTS2 SPINAL FIXATION SYSTEM
- K110633 — LANCER PEDICLE SCREW SYSTEM
- K111995 — XINGTM SPINE SYSTEM
- K111690 — DEVINE SPINAL SYSTEM
- K110497 — PASS LP SPINAL SYSTEM
- K111370 — ODALYS PEDICLE SCREW SYSTEM
- K111362 — REXIOUS SPINAL FIXATION SYSTEM
- K102458 — 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
- K110321 — TIGER SPINE SYSTEM
- K101374 — AAXTER A3 POSTERIOR SPINAL SYSTEM
- K102574 — PALLA M SPINAL SYSTEM
- K102636 — ZENITH PEDICLE SYSTEM
- K101818 — 4CIS VANE SPINE SYSTEM
- K103085 — VENUS BASIC SPINAL FIXATION SYSTEM
- K102853 — FLAMENCO SPINAL FIXATION SYSTEM
- K102870 — EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
- K101446 — EMERALD SPINAL SYSTEM
- K101278 — INERTIA PEDICLE SCREW SYSTEM
- K102488 — APEX SPINE SYSTEM W/ COCR RODS
- K093771 — QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM
- K101678 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K100706 — VENUS BASIC SPINAL FIXATION SYSTEM
- K100956 — SPONDY SPINAL FIXATION SYSTEM
- K100373 — TYCHE PEDICLE SCREW SYSTEM
- K100605 — MIS SYSTEM
- K093670 — MODIFICATION TO: OASYS SYSTEM
- K100122 — MODIFICATION TO CAPSURE PS SYSTEM
- K091725 — PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)
- K092011 — NORM SPINAL SYSTEM
- K083077 — ULC SPINAL PEDICLE SCREW SYSTEM
- K083567 — GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW
- K090224 — FORTEX PEDICLE SCREW SYSTEM
- K090477 — ALPINE PEDICLE SCREW SYSTEM
- K091110 — SPINAL EDGE TITAN PEDICLE SCREW SYSTEM
- K090424 — DVX SPINE SYSTEM
- K090228 — ROC LUMBAR PLATING SYSTEM
- K083581 — LANX SPINAL FIXATION SYSTEM
- K080611 — MESA SPINAL SYSTEM
- K081153 — NOVEL SPINAL SYSTEM
- K083826 — LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM
- K081165 — ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM
- K082509 — EOS SPINAL SYSTEM
- K082577 — PASS LP SPINAL SYSTEM
- K081883 — MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM
- K082453 — 4CIS SOLAR AND APOLLON SPINE SYSTEMS
- K081331 — FIXXSURE CROSS LINK
- K081631 — SINTEA BIOTECH PLS MULTI-AXIAL SCREWS
- K080828 — MOUNTAINEER OCT SPINAL SYSTEM
- K081041 — GPS, G SURGICAL PEDICLE SYSTEM
- K081381 — RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
- K081296 — PREFERENCE PEDICLE SCREW SYSTEM
- K080876 — DVX SPINE SYSTEM
- K073531 — ACCIN PEDICLE SCREW SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.