FDA.reportPublic FDA data

LumFix Spinal Fixation System

Primary DI
08809658601803
Brand
LumFix Spinal Fixation System
Company
CG Bio Co., Ltd.
Model
RDPS5035
Device description
Regulation Name: Pedicle screw spinal system
Published
2019-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160731000LumFix Spinal Fixation SytemCG Bio Co., Ltd.2016-10-04MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809658601803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809658601803088096586018038809658601803

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
631130655
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809429616364LumFix spinal fixation systemRDPS55302021-02-03
08809658605566LumFix spinal fixation systemRDPS50302020-07-27
08809304756819LumFix Spinal Fixation SystemMSS45402017-01-31
08809429614858LumFix Spinal Fixation SystemRODCR551002019-12-02
08809550978768LumFix Spinal Fixation SystemNPSS45302019-10-30
08809304757687LumFix Spinal Fixation SystemRODST551002019-10-18
08809429619105LumFix Spinal Fixation SystemDPS55402019-10-18
08809429619112LumFix Spinal Fixation SystemDPS55452019-10-18
08809429619129LumFix Spinal Fixation SystemDPS55502019-10-18
08809429619204LumFix Spinal Fixation SystemDPS65352019-10-18
08809429619211LumFix Spinal Fixation SystemDPS65402019-10-18
08809429619228LumFix Spinal Fixation SystemDPS65452019-10-18
08809429619235LumFix Spinal Fixation SystemDPS65502019-10-18
08809429619242LumFix Spinal Fixation SystemDPS65552019-10-18
08809429619303LumFix Spinal Fixation SystemDPS75352019-10-18
08809429619310LumFix Spinal Fixation SystemDPS75402019-10-18
08809429619327LumFix Spinal Fixation SystemDPS75452019-10-18
08809429619334LumFix Spinal Fixation SystemDPS75502019-10-18
08809429619341LumFix Spinal Fixation SystemDPS75552019-10-18
08809304756987LumFix Spinal Fixation SystemRODCR55402019-10-17

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