Malibu

Primary DI
10381780002185
Brand
Malibu
Company
Seaspine, Inc.
Model
13-8080
Catalog number
13-8080
Device description
Malibu Polyaxial Reduction Screw,8.0 x 80mm
Published
2017-02-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780002185PrimaryGS10
M5561380801SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178000218510381780002185

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
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119614407
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780000662UCR10-474010-47402014-09-18
10381780000679UCR10-474510-47452014-09-18
10381780000686UCR10-475010-47502014-09-18
10381780000693UCR10-475510-47552014-09-18
10381780000709UCR10-602510-60252014-09-18
10381780000716UCR10-603010-60302014-09-18
10381780000723UCR10-803010-80302014-09-18
10381780000730UCR11-472511-47252014-09-18
10381780000747UCR11-473011-47302014-09-18
10381780000754UCR11-473511-47352014-09-18
10381780000761UCR11-474011-47402014-09-18
10381780000778UCR11-474511-47452014-09-18
10381780000785UCR11-475011-47502014-09-18
10381780000792UCR11-475511-47552014-09-18
10381780000808UCR11-555511-55552014-09-18
10381780000815UCR11-602511-60252014-09-18
10381780000822UCR11-603011-60302014-09-18
10381780000839UCR11-603511-60352014-09-18
10381780000846UCR11-604011-60402014-09-18
10381780000853UCR11-604511-60452014-09-18

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Primary DI, Brand, Company table
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