FDA.reportPublic FDA data

True Spinal Fixation System

Primary DI
B50610593027401
Brand
True Spinal Fixation System
Company
INNOVATIVE SURGICAL DESIGNS
Model
105-9-302-740
Device description
7.5mm x 40mm Extended Reduction Polyaxial Pedicle Screw
Published
2017-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B50610593027401PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of 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. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
078306079
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B50620593085351True Tulip Spinal Fixation System205-9-308-5352020-02-11
B50620593085401True Tulip Spinal Fixation System205-9-308-5402020-02-11
B50620593085451True Tulip Spinal Fixation System205-9-308-5452020-02-11
B50620593085501True Tulip Spinal Fixation System205-9-308-5502020-02-11
B50620593086351True Tulip Spinal Fixation System205-9-308-6352020-02-11
B50620593086401True Tulip Spinal Fixation System205-9-308-6402020-02-11
B50620593086451True Tulip Spinal Fixation System205-9-308-6452020-02-11
B50620593086501True Tulip Spinal Fixation System205-9-308-6502020-02-11
B50620593087351True Tulip Spinal Fixation System205-9-308-7352020-02-11
B50620593087401True Tulip Spinal Fixation System205-9-308-7402020-02-11
B50620593087451True Tulip Spinal Fixation System205-9-308-7452020-02-11
B50620593087501True Tulip Spinal Fixation System205-9-308-7502020-02-11
B506L205933850301True Tulip Spinal Fixation SystemL-205-9-338-50302020-02-11
B506L205933850351True Tulip Spinal Fixation SystemL-205-9-338-50352020-02-11
B506L205933850401True Tulip Spinal Fixation SystemL-205-9-338-50402020-02-11
B506L205933850451True Tulip Spinal Fixation SystemL-205-9-338-50452020-02-11
B506L205933850501True Tulip Spinal Fixation SystemL-205-9-338-50502020-02-11
B506L205933850551True Tulip Spinal Fixation SystemL-205-9-338-50552020-02-11
B506L205933850601True Tulip Spinal Fixation SystemL-205-9-338-50602020-02-11
B506L205933850651True Tulip Spinal Fixation SystemL-205-9-338-50652020-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
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
06009699901067Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901074Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901081Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28