Product Code: MNH


Products Classified as MNH

4623Orthosis, Spondylolisthesis Spinal FixationThoracolumbosacral Pedicle Screw System.

Total Product Life Cycle (TPLC) Devices

4623Orthosis, Spondylolisthesis Spinal FixationThoracolumbosacral Pedicle Screw System.

FDA Consensus Standards

Orthosis, Spondylolisthesis Spinal Fixation [37410]21 CFR §888.3070 🔎
Orthosis, Spondylolisthesis Spinal Fixation [37411]21 CFR §888.3070 🔎
Orthosis, Spondylolisthesis Spinal Fixation [35610]21 CFR §888.3070 🔎
Orthosis, Spondylolisthesis Spinal Fixation [37829]21 CFR §888.3070 🔎
Orthosis, Spondylolisthesis Spinal Fixation [38313]21 CFR §888.3070 🔎
Orthosis, Spondylolisthesis Spinal Fixation [38312]21 CFR §888.3070 🔎
Orthosis, Spondylolisthesis Spinal Fixation [37861]21 CFR §888.3070 🔎
Orthosis, Spondylolisthesis Spinal Fixation [32387]21 CFR §888.3070 🔎
Orthosis, Spondylolisthesis Spinal Fixation [37390]21 CFR §888.3070 🔎
Orthosis, Spondylolisthesis Spinal Fixation [34069]21 CFR §888.3070 🔎

Pre-market Notifications for MNH

K162801CastleLoc Spinal Fixation SystemL&K BIOMED CO., LTD.
K162189ANAXâ„¢ 5.5 Spinal SystemU&I Corporation
K162143FixxSure® X-LinkINNOVASIS, INC.
K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC
K161151Spinal Fixation SystemCANWELL MEDICAL CO., LTD.
K160020Captiva Spine And CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine
K153404Zavation Spinal SystemZAVATION, LLC
K151695Romeo Posterior Osteosynthesis SystemSPINEART
K151362HC Spinal SystemHUNG CHUN BIO-S CO., LTD.
K151116CapLOX II/TowerLOX Pedicle Screw SystemCAPTIVA SPINE
K150283Republic Spine Dark Star Spinal SystemREPUBLIC SPINE, LLC
K143417ANAX 5.5 Spinal SystemU&I Corporation
K143377PedFuse Pedicle Screw SystemSPINEFRONTIER, INC.
K143013Spinal Inner Fixation SystemChangzhou Dingjian Medical Appliance Co., Ltd
K142957Ideal Pedicle Screw Spinal SystemJIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD.

Global Unique Device Identification Database

00613994953209Orthosis, spondylolisthesis spinal fixation
00613994953179Orthosis, spondylolisthesis spinal fixation
00613994953162Orthosis, spondylolisthesis spinal fixation
00613994953155Orthosis, spondylolisthesis spinal fixation
00613994953148Orthosis, spondylolisthesis spinal fixation
00613994953131Orthosis, spondylolisthesis spinal fixation
00613994953100Orthosis, spondylolisthesis spinal fixation
00613994953094Orthosis, spondylolisthesis spinal fixation
00613994951021Orthosis, spondylolisthesis spinal fixation
00613994950925Orthosis, spondylolisthesis spinal fixation
00613994950857Orthosis, spondylolisthesis spinal fixation
00613994950840Orthosis, spondylolisthesis spinal fixation
00613994950826Orthosis, spondylolisthesis spinal fixation
00613994950758Orthosis, spondylolisthesis spinal fixation
00613994950734Orthosis, spondylolisthesis spinal fixation

Maude Adverse Events

UNKNOWN MONO/POLYAXIAL SCREWSDEPUY SPINE INC2020-03-30
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESMEDOS INTERNATIONAL SàRL CH2020-03-30
UNKNOWN MONO/POLYAXIAL SCREWSDEPUY SPINE INC2020-03-30
UNKNOWN MONO/POLYAXIAL SCREWSDEPUY SPINE INC2020-03-30
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESMEDOS INTERNATIONAL SàRL CH2020-03-25
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESMEDOS INTERNATIONAL SàRL CH2020-03-25
UNK - MONO/POLYAXIAL SCREW COLLARS/SLEEVES/HEADS: MATRIXOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-20
EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5MEDOS INTERNATIONAL SàRL CH2020-03-17
JANUSORTHOFIX MEDICAL INC2020-03-16
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESMEDOS INTERNATIONAL SàRL CH2020-03-13
UNK - CONSTRUCTS: USSOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-13
UNKNOWN MONO/POLYAXIAL SCREWSMEDOS INTERNATIONAL SàRL CH2020-03-13
FORTEX PEDICLE SCREW SYSTEMX-SPINE SYSTEMS, INC.2020-03-11
UNKNOWN MONO/POLYAXIAL SCREWSMEDOS INTERNATIONAL SàRL CH2020-03-11
UNKNOWN MONO/POLYAXIAL SCREWSMEDOS INTERNATIONAL SàRL CH2020-03-11
UNKNOWN MONO/POLYAXIAL SCREWSMEDOS INTERNATIONAL SàRL CH2020-03-11
UNKNOWN MONO/POLYAXIAL SCREWSMEDOS INTERNATIONAL SàRL CH2020-03-11
UNK - CONSTRUCTS: PFNAOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-06
UNKNOWN LOCKING/SET SCREWSMEDOS INTERNATIONAL SàRL CH2020-03-05
6.5 X 45MM MULTIAXIAL SCREWZIMMER BIOMET SPINE INC.2020-03-03
50MM TI ALLOY CURVED RODZIMMER BIOMET SPINE INC.2020-02-28
50MM TI ALLOY CURVED RODZIMMER BIOMET SPINE INC.2020-02-28
DEROTATION PLUGZIMMER BIOMET SPINE INC.2020-02-28
DEROTATION PLUGZIMMER BIOMET SPINE INC.2020-02-28
DEROTATION PLUGZIMMER BIOMET SPINE INC.2020-02-28
DEROTATION PLUGZIMMER BIOMET SPINE INC.2020-02-28
6.5 X 50MM MULTIAXIAL SCREWZIMMER BIOMET SPINE INC.2020-02-28
6.5 X 50MM MULTIAXIAL SCREWZIMMER BIOMET SPINE INC.2020-02-28
6.5 X 50MM MULTIAXIAL SCREWZIMMER BIOMET SPINE INC.2020-02-28
6.5 X 50MM MULTIAXIAL SCREWZIMMER BIOMET SPINE INC.2020-02-28
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESMEDOS INTERNATIONAL SàRL CH2020-02-28
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESMEDOS INTERNATIONAL SàRL CH2020-02-28
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESMEDOS INTERNATIONAL SàRL CH2020-02-28
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESMEDOS INTERNATIONAL SàRL CH2020-02-28
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESMEDOS INTERNATIONAL SàRL CH2020-02-28
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESMEDOS INTERNATIONAL SàRL CH2020-02-25
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESMEDOS INTERNATIONAL SàRL CH2020-02-25
OMEGA-21 VERTEBRAL FIXATION SYSTEMBIOMET SPAIN, S.L.2020-02-21
TI LOW PROFILE TRANSCONNECTOR 42MM-55MM FOR 6.0MM RODSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-18
UNKNOWN LOCKING/SET SCREWSMEDOS INTERNATIONAL SàRL CH2020-02-13
UNKNOWN SCREWSMEDOS INTERNATIONAL SàRL CH2020-02-13
UNKNOWN RODSMEDOS INTERNATIONAL SàRL CH2020-02-13
UNKNOWN LOCKING/SET SCREWSMEDOS INTERNATIONAL SàRL CH2020-02-13
UNKNOWN SCREWSMEDOS INTERNATIONAL SàRL CH2020-02-13
UNKNOWN RODSMEDOS INTERNATIONAL SàRL CH2020-02-13
UNK - LOCKING/SET SCREWS: USSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-10
UNK - LOCKING/SET SCREWS: USSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-10
PSS SYSTEMPRECISION SPINE, INC.2020-02-10
UNKNOWN CAGE/SPACERMEDOS INTERNATIONAL SàRL CH2020-02-06
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESMEDOS INTERNATIONAL SàRL CH2020-02-06
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