FDA.reportPublic FDA data

Galaxy Mis Screw System

Primary DI
08809255540482
Brand
Galaxy Mis Screw System
Company
BM KOREA CO., LTD
Model
GC300-5575
Device description
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
Published
2017-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143110000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143110000GALAXY MIS Screw SystemBm Korea2015-06-24NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809255540482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809255540482088092555404828809255540482

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length75Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
557799209
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
08809255540024Galaxy Mis Screw SystemGXMS-55302017-07-11
08809255540031Galaxy Mis Screw SystemGXMS-55352017-07-14
08809255540048Galaxy Mis Screw SystemGXMS-55402017-07-14
08809255540055Galaxy Mis Screw SystemGXMS-55452017-07-14
08809255540062Galaxy Mis Screw SystemGXMS-55502017-07-14
08809255540079Galaxy Mis Screw SystemGXMS-55552017-07-14
08809255540086Galaxy Mis Screw SystemGXMS-55602017-07-14
08809255540093Galaxy Mis Screw SystemGXMS-65302017-07-14
08809255540109Galaxy Mis Screw SystemGXMS-65352017-07-14
08809255540116Galaxy Mis Screw SystemGXMS-65402017-07-14
08809255540123Galaxy Mis Screw SystemGXMS-65452017-07-14
08809255540130Galaxy Mis Screw SystemGXMS-65502017-07-14
08809255540147Galaxy Mis Screw SystemGXMS-65552017-07-14
08809255540154Galaxy Mis Screw SystemGXMS-65602017-07-14
08809255540161Galaxy Mis Screw SystemGXMS-75302017-07-14
08809255540178Galaxy Mis Screw SystemGXMS-75352017-07-14
08809255540185Galaxy Mis Screw SystemGXMS-75402017-07-14
08809255540192Galaxy Mis Screw SystemGXMS-75452017-07-14
08809255540208Galaxy Mis Screw SystemGXMS-75502017-07-14
08809255540215Galaxy Mis Screw SystemGB300-55352017-07-14

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