FDA.reportPublic FDA data

True Spinal Fixation System

Primary DI
B5061059318SL1
Brand
True Spinal Fixation System
Company
INNOVATIVE SURGICAL DESIGNS
Model
105-9-318-SL
Device description
Straight Lenke Gearshift Probe
Published
2017-03-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133690000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133690000TRUE SPINAL FUSSION SYSTEMInnovative Surgical Designs2014-05-07MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B5061059318SL1PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
8123694252xx@xx.xx

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
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-06-28
10889981065348MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065348MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065645MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065645MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065669MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065669MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981005115NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005115NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationMNI2015-09-24