Product code MNI— Orthopedic
CD HORIZON SPINAL SYSTEM
- Classification name
- Orthosis, Spinal Pedicle Fixation
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Total cleared
- 303
- First cleared
- Most recent
Market context for product code MNI
FDA has cleared devices under product code MNI between 1998 and 2017, filed by 126 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- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
Top applicants under product code MNI
Adverse events under product code MNI
product code MNI- Injury
- 641
- Total
- 641
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 MNI
1–100 of 303- K171497 — Mikron Spinal Fixation System
- K160731 — LumFix Spinal Fixation Sytem
- K151458 — Double Medical Universal Spine System
- K153273 — MySpine Pedicle Screw Placement Guides - LP
- K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
- K160320 — Premier
- K160003 — Sniper (R) Spine System
- K152324 — YAHUA Spinal System
- K143222 — FIREFLY Pedicle Screw Navigation Guide
- K150684 — WASTON General Spinal System
- K152132 — X-spine Pedicle Screw System
- K151592 — Gemmed pedicle screw spinal system
- K152098 — ODALYS Pedicle Screw System
- K152131 — Reliance Spinal Screw System
- K152174 — Sniper Spine System
- K151813 — Sniper Spine System
- K150294 — DPZ Pedicular Fixation System
- K150647 — Polyscrew Pedicle Screw System
- K150049 — PASS LP Spinal System
- K141253 — NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
- K140738 — PASS LP SPINAL SYSTEM
- K141835 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS
- K141397 — SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
- K132788 — MYSPINE PEDICLE SCREW PLACEMENT GUIDES
- K140229 — GENERAL SPINAL SYSTEM
- K133103 — AVERSION PEDICLE SCREW SYSTEM
- K130073 — MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS
- K132757 — EVEREST SPINAL SYSTEM
- K132280 — ALTUS SPINE PEDICLE SCREW SYSTEM
- K130958 — TRUE SPINAL FIXATION SYSTEM
- K132412 — INERTIA MIS PEDICLE SCREW SYSTEM
- K132361 — EVEREST SPINAL SYSTEM
- K132644 — LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
- K132365 — SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
- K131522 — CORE PEDICLE SCREW SYSTEM
- K132154 — CAPSURE PS SYSTEM
- K130302 — SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT
- K131343 — REFORM PEDICLE SCREW SYSTEM
- K130279 — REFORM PEDICLE SCREW SYSTEM
- K123521 — RELIANCE SPINAL SCREW SYSTEM
- K122931 — S-LOK PSS SYSTEM
- K122163 — CERTEX SPINAL IMPLANT SYSTEM
- K122332 — TOWERLOX PEDICLE SCREW SYSTEM
- K122233 — CAPSURE(R) PS SYSTEM
- K121615 — 4CIS VANE SPINE SYSTEM
- K121172 — REFORM PEDICLE SCREW SYSTEM
- K120646 — CAPSURE(R) PS SYSTEM
- K120899 — RANGE SPINAL SYSTEM, UNIT ROD
- K120879 — LEXUS CERVICAL FIXATION SYSTEM
- K120099 — RANGE SPINAL SYSTEM (MESA AND DENALI)
- K112611 — SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
- K120292 — CAPLOX II PEDICLE SCREW SYSTEM
- K120656 — EVEREST SPINAL SYSTEM
- K120696 — TIGER SPINE SYSTEM
- K120538 — PALLS M SPINAL SYSTEM
- K113157 — AILERON INTERSPINOUS FIXATION SYSTEM
- K113149 — SYNTHES USS CONNECTORS
- K113755 — SAVANNAH TECHNOLOGIES SPINAL SYSTEM
- K110896 — RELIANCE SPINAL SCREW SYSTEM
- K112920 — RANGE SPINAL SYSTEM (MESA AND DENALI)
- K112484 — ZAVATION SPINAL SYSTEM
- K112493 — PASS LP SPINAL SYSTEM
- K111883 — SMARTLOC SPINAL FIXATION SYSTEM
- K112037 — RANGE SPINAL SYSTEM (MESA AND DENALI)
- K111115 — CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM
- K111913 — CAPSURE(R) PS SYSTEM
- K112108 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K111127 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K110991 — MESA SPINAL SYSTEM (KEYSTONE RODS)
- K103414 — VENUS CERVICAL SPINAL FIXATION SYSTEM
- K110197 — EXACTECH GIBRALT SPINAL SYSTEM
- K110284 — NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
- K110283 — ZENIUS SPINAL SYSTEM
- K103440 — EVEREST SPINAL SYSTEM
- K103102 — LEUCADIA PEDICLE SCREW SYSTEM
- K102995 — TALON SPINAL SYSTEM
- K103272 — ZENIUS SPINAL SYSTEM
- K103147 — NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
- K101682 — S 100 PEDICLE SCREW SYSTEM
- K103100 — MOUNTAINEER OCT SPINAL SYSTEM
- K100407 — LIFE SPINE INTERSPINOUS FIXATION SYSTEM
- K093833 — KAPSS SPINAL SYSTEM
- K102331 — LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
- K100851 — RANGE SPINAL SYSTEM
- K100765 — FIXPINE II SYSTEM
- K093104 — MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM
- K100377 — DIAMONDBACK SPINAL SYSTEM
- K092076 — AEGIS & AEGIS II SPINAL SYSTEM
- K100575 — LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
- K093936 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K100297 — PASS LP SPINAL SYSTEM
- K100138 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K093077 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K093285 — MODIFICATION TO LANX SPINAL FIXATION SYSTEM
- K092420 — KRD1 PEDICLE SCREW SYSTEM
- K092640 — CASPIAN SPINAL SYSTEM
- K093170 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K092128 — MODIFICATION TO: PSS SYSTEM
- K083810 — PASS LP SPINAL SYSTEM
- K091189 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.