FDA.reportPublic FDA data

Pedicle Screw

Primary DI
B5231000026045
Brand
Pedicle Screw
Company
Eisertech, LLC
Model
100002-6045C
Catalog number
100002-6045C
Device description
CANNULATED MODULAR PEDICLE SCREW 6.0 X 45
Published
2018-04-09
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
KWPAppliance, Fixation, Spinal Interlaminal
KWQAppliance, Fixation, Spinal Intervertebral Body
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B5231000026045PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
965627297
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B5231003204525Pedicle Screw100320-4525D100320-4525D2019-08-19
B5231003204530Pedicle Screw100320-4530D100320-4530D2019-08-19
B5231003204555Pedicle Screw100320-4555D100320-4555D2019-08-19
B5231003204560Pedicle Screw100320-4560D100320-4560D2019-08-19
B5231003205525Pedicle Screw100320-5525D100320-5525D2019-08-19
B5231003206525Pedicle Screw100320-6525D100320-6525D2019-08-19
B5231003206565Pedicle Screw100320-6565D100320-6565D2019-08-19
B5231003206570Pedicle Screw100320-6570D100320-6570D2019-08-19
B5231003207525Pedicle Screw100320-7525D100320-7525D2019-08-19
B5231003207565Pedicle Screw100320-7565D100320-7565D2019-08-19
B5231003207570Pedicle Screw100320-7570D100320-7570D2019-08-19
B5231003207575Pedicle Screw100320-7575D100320-7575D2019-08-19
B5231003207580Pedicle Screw100320-7580D100320-7580D2019-08-19
B5231003208570Pedicle Screw100320-8570D100320-8570D2019-08-19
B5231003208580Pedicle Screw100320-8580D100320-8580D2019-08-19
B5231003208590Pedicle Screw100320-8590D100320-8590D2019-08-19
B5231000024530Pedicle Screw100002-4530C100002-4530C2018-04-09
B5231000025025Pedicle Screw100002-5025C100002-5025C2018-04-09
B5231000025030Pedicle Screw100002-5030C100002-5030C2018-04-09
B5231000025035Pedicle Screw100002-5035C100002-5035C2018-04-09

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