FDA.reportPublic FDA data

Pedicle Screw

Primary DI
B52310018055055
Brand
Pedicle Screw
Company
Eisertech, LLC
Model
100180-55055
Catalog number
100180-55055
Device description
5.5mm DIA x 055mm L Straight Rod
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
B52310018055055PrimaryHIBCC0

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
03700780634583Erisma®-LPCLARIANCEMNH2026-05-28
03700780634583Erisma®-LPCLARIANCEMNI2026-05-28
04052536085491neon3Ulrich GmbH & Co. KGKWP2026-05-28
06009699900008Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900503Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900831Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900848Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900855Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900862Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900879Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900886Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900893Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900909Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900916Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900923Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900930Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900947Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900954Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900961Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900978Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900985Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900992Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901005Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901012Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901029Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901036Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901050Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28