Product Code: MNH FDA class 2 21 CFR 888.3070

Orthosis, Spondylolisthesis Spinal Fixation

Orthopedic

The Orthosis, Spondylolisthesis Spinal Fixation is an orthopedic implant used to stabilize the spine in patients with spondylolisthesis, a condition where one vertebra slips forward over another. It is classified as FDA Class 2, requiring 510(k) premarket notification under 21 CFR 888.3070 in the Orthopedic specialty. The product code is MNH, and the device carries an implant flag indicating it is surgically placed within the body.

510(k)s
309
FEI Numbers
338
Registration Numbers
338
Unique Applicants
150
Years Active
22

Basic Information

Product Code
MNH
Device Class
FDA class 2
Regulation Number
888.3070
Medical Specialty
Orthopedic
Review Panel
OR
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 309 510(k) clearances via K numbers.

K Number Device Name
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
K141376 INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
K140053 KANGLI PEDICLE SCREW SPINAL SYSTEM
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
K131810 OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM
K131538 CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX 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
K121016 RANGE SPINAL SYSTEM (MESA AND DENALI)
K120760 LDR SPINE SPINETUNE TL SPINAL SYSTEM
K111940 S 100 PEDICLE SCREW SYSTEM
K120491 DSS STABILIZATION SYSTEM-RIGID
K120353 SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
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
K081041 GPS, G SURGICAL PEDICLE SYSTEM
K080828 MOUNTAINEER OCT SPINAL SYSTEM
K081381 RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K081296 PREFERENCE PEDICLE SCREW SYSTEM
K080876 DVX SPINE SYSTEM
K073531 ACCIN PEDICLE SCREW SYSTEM
K071890 ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
K070530 MODIFICATION TO PASSMED SPINAL SYSTEM
K072282 CAPLESS LI PEDICLE SCREW SYSTEM
K070933 LOWTOP PEDICLE SCREW SYSTEM
K062670 VERTIFLEX SPINAL SCREW SYSTEM
K062174 MODIFICATION TO EXPEDIUM SPINE SYSTEM
K061524 ISS INTEGRATED SPINE SYSTEM
K061813 MANTIS SPINAL SYSTEM
K061577 OVALTWIST PEDICLE SCREW SYSTEM
K062196 SFX SNAP-FIT CROSS CONNECTOR
K061364 PILOT POSTERIOR LUMBAR PLATING SYSTEM
K062317 MODIFICATION TO NUVASIVE SPHERX II SYSTEM
K061162 BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020
K061915 CD HORIZON SPINAL SYSTEM
K061441 EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
K061778 NUVASIVE SPHERX II SYSTEM
K053623 NFIX FUSION SYSTEM
K061321 ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX
K060702 4CIS VANE SPINE SYSTEM
K060118 SSP PEDICLE SCREW SYSTEM
K060225 NUVASIVE SPHERX SYSTEM
K053573 GSS PEDICLE SCREW SYSTEM
K053070 CONTOUR II SPINAL SYSTEM
K051089 GII SPINAL FIXATION SYSTEM
K051959 NV CORMED SOLAS SPINAL SYSTEM
K051044 ARCTEC SEMIRIGID PLATING SYSTEM
K051697 SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
K050461 XIA 4.5 SPINAL SYSTEM
K051216 HYDRALOK SYSTEM
K051286 ZODIAC SPINAL FIXATION SYSTEM
K050471 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K043578 THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM
K043180 STRYKER SPINE TRIO PS
K050078 ROC LUMBAR PLATING SYSTEM
K042928 MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
K043152 VERTEBRON PSS PEDICLE SCREW SYSTEM
K043343 MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043001 MX POLYAXIAL PEDICLE SCREW
K042640 UNI-THREAD SPINAL SYSTEM
K042964 MX MONOAXIAL PEDICLE SCREW
K040747 ALADYN RIGID SPINE PLATE
K033512 PROCYON SPINAL SYSTEM
K040442 PROTEX STABILIZATION SYSTEM
K034056 MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033546 NUVASIVE SPINAL SYSTEM
K040072 MODIFICATION TO CD HORIZON SPINAL SYSTEM
K032604 GII SPINAL FIXATION SYSTEM
K033322 MODIFICATION TO CD HORIZON SPINAL SYSTEM
K032855 STRYKER SPINE MAPS SYSTEM
K031265 SHIRAZ-JAVA SPINAL FIXATION SYSTEM
K031585 U&I, OPTIMA, SPINAL SYSTEM
K031423 EBI P148 SPINAL FIXATION SYSTEM
K023378 ORIA CLARIS
K030581 BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K031290 MODIFICATION TO EASYS TRANSVERSE CONNECTION
K030383 MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K023994 ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
K024348 MONARCH SPINE SYSTEM
K020085 SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
K023438 MODIFICATION TO MONARCH SPINE SYSTEM
K023204 MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
K021623 UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS
K021881 ENDIUS TITLE SPINAL FIXATION SYSTEM
K020356 ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K020247 COLORADO 2 SPINAL SYSTEM
K021335 MONARCH SPINE SYSTEM
K021880 CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)
K021879 CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)
K013962 EQUATION FIXATION SYSTEM
K020699 TSRH SPINAL SYSTEM
K021148 MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD
K020681 EBI OMEGA21 SPINAL FIXATION SYSTEM
K020674 BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
K014302 UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
K020196 MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K020293 OSTEONICS SPINAL SYSTEM
K013887 BACFIX SPINAL FIXATION SYSTEM
K020245 MODIFICATION TO ISOBAR SPINAL SYSTEM
K014229 MODIFICATION TO OPUS SPINAL SYSTEM
K014137 MODIFICATION TO EBI OMEGA 21 SYSTEM
K014076 MODIFICATION TO TSRH SPINAL SYSTEM
K013688 MODIFICATION TO XIA SPINAL SYSTEM
K013444 ISOBAR SPINAL SYSTEM
K013296 MOSS MIAMI SPINAL SYSTEMS
K013295 TIMX SPINAL SYSTEMS
K013294 MONARCH SPINAL SYSTEMS
K012971 ISOLA SPINAL SYSTEMS
K012273 SPIRAL RADIUS 90-D SST SYSTEM
K012027 MODIFICATION TO XIA SPINE SYSTEM
K003733 SCS CLOSED SCREW
K011182 MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
K010369 CLARIS PLATE SYSTEM
K010845 MODIFICATION TO OSTEONICS SPINAL SYSTEM
K010742 MOSS MIAMI 5.5MM TITANIUM PIN NUT
K010720 TSRH SPINAL SYSTEM
K003463 SOCON SPINAL SYSTEM
K010776 TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS
K010535 TRIFIX SPINAL FIXATION SYSTEM
K010249 CD HORIZON SPINAL SYSTEM
K003764 MODIFICATION TO EBI SPINELINK SYSTEM
K000641 CD HORIZON SPINAL SYSTEM
K003490 OPUS ROD FIXATION SYSTEM
K003384 VERSALINK TITANIUM ROD-TO-ROD COUPLERS
K001044 ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
K001668 GLOBAL SPINAL FIXATION SYSTEM
K002399 MODIFICATION TO CD HORIZON SPINAL SYSTEM
K001255 CD HORIZON SPINAL SYSTEM
K001066 CD HORIZON ECLIPSE
K001627 TRIFIX SPINAL FIXATION SYSTEM
K001319 XIA SPINE SYSTEM HOOKS
K001024 PASS SPINAL SYSTEM
K991031 COLORADO II SPINAL SYSTEM
K993503 HAIDER-UCR SPINAL SYSTEM
K994288 5.0MM SPINAL SCREWS
K984360 COLORADO II SPINAL SYSTEM
K000476 MODIFICATION TO CD SPINAL SYSTEM
K000453 MODIFICATION TO CD SPINAL SYSTEM
K994217 BLACKSTONE SPINAL FIXATION SYSTEM
K992739 CLICK'X
K000094 MODIFICATION TO CD HORIZON SPINAL SYSTEM
K993810 CD HORIZON SPINAL SYSTEM
K000020 MODIFICATION TO ISOBAR SPINAL SYSTEM
K993551 SOCON SPINAL SYSTEM
K993926 OMNIAXIAL CONNECTOR
K993808 SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220
K991036 DANEK PLATE AND SCREW SYSTEM
K991055 OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM
K991552 SYNTHES PEDIATRIC ROD SYSTEM
K991528 MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
K990721 ISOLOCK SPINAL SYSTEM
K991460 MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K991364 MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
K990657 TRIFIX PEDICLE SPINAL SCREW ASSEMBLY
K990118 ISOBAR SPINAL SYSTEM
K984302 OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS
K983152 OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS
K980761 SYNTHES SPINE PEDIATRIC ROD SYSTEM
K981714 TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM
K981113 PEDIATRIC PRC
K980862 TITANIUM SPINAL ROD SYSTEM
K980852 GII SPINAL FIXATION SYSTEM
K981274 ACROMED TIMX PLATE BASED LOW BACK SYSTEM
K980496 WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER
K980447 DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K973687 SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM
K974749 SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS
K974734 AURORA TITANIUM SPINAL ROD SYSTEM
K973836 SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM
K973425 THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM
K974213 AURORA TITANIUM SPINAL ROD SYSTEM
K973683 OMEGA 21 SYSTEM
K972568 DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K971970 EBI SPINELINK SYSTEM
K970285 AESUCLAP SOCON SPINAL SYSTEM
K970950 EASY ROD
K965102 ACROMED PEDICLE SCREW
K964533 EBI SPINELINK SYSTEM
K965046 ISOLA TWISTER CONNECTOR
K963045 SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM
K964544 OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY
K964304 OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY
K950099 SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM
K963357 MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE
K964007 ACROMED CABLE/WIRE PEDICLE SCREW
K962608 SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962645 ISOLA TWISTER CONNECTOR
K962784 ULTIUM SPINAL PLATING SYSTEM
K962757 J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP
K961572 VERSALOK SCREW ASSEMBLY (PROPOSED NAME)
K960107 DDS SPINAL SYSTEM
K960451 WEBB-MORLEY SPINE SYSTEM
K953881 SPINE SYSTEM SACRAL PLATE
K953915 MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)
K950717 AUGMENT-T POSTERIOR SPINAL SYSTEM
K943827 SPINE FIXATION
K950999 KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS
K952236 ISOLA SYSTEM
K952298 SPINAL PEDICLE SCREW, FIXATION, APPLIANCE
K951266 AMSET R-F SYSTEM
K953779 SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM
K953778 SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM
K953635 TITANIUM DYNA-LOK SPINAL SYSTEM
K953416 BRYAN POSTERIOR SPINAL FIXATOR (BPSF)
K953369 STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW
K951725 OSTEONICS SPINAL SYSTEM
K950865 ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT
K950596 GDLH POSTERIOR SPINAL SYSTEM
K950955 PARAGON POSTERIOR SPINAL SYSTEM
K951794 SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)
K951657 VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S)
K951626 SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM
K936307 DYNA-LOK ANTERIOR PLATING SYSTEM
K951116 ACROMED PEDICLE SCREW
K950074 WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM
K946348 TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)
K951308 5.8MM DIAMETER ANCHOR SCREW
K951172 TITANIUM LOW PROFILE CROSS BAR
K950695 DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATION
K940631 CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM
K950697 DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION
K944737 ISOLA SPINE SYSTEM
K930353 SIMMONS PLATING SYSTEM BOLT AND SCREW
K930298 ROGOZINSKI SPINAL ROD SYSTEM SCREW
K944756 ISOLA OPEN AND CLOSED SCREWS
K944736 VSP (VARIABLE SCREW PLACEMENT)
K945064 SELBY INSTRUMENTATION
K943775 SELBY INSTRUMENTATION
K942387 SELBY INSTRUMENTATION
K932029 TSRH SPINAL SCREWS

FEI Numbers

This FDA classification entry is associated with 338 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 338 registration numbers. Click on an entry to view related FDA registrations.