FDA.reportPublic FDA data

SpineTune TL

Primary DI
03662663008082
Brand
SpineTune TL
Company
LDR Spine Usa, Inc.
Model
ST6457T-S
Device description
CANNUL. POLY. SCREW D7.5 L60MM
Published
2015-10-24
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
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102331000LDR SPINE USA SPINETUNE TL SPINAL SYSTEMLdr Spine USA2010-10-15MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663008082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663008082036626630080823662663008082

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Millimeter
Outer Diameter7.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
512-344-3333surgeoninfo@ldrspine.com

Regulatory Flags#

DUNS number
615789729
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662663000369Mobi-CMB942RMB942R2018-12-12
03662663002899Avenue TAT9033RAT9033R2017-04-12
03662663002912Avenue TAT9035RAT9035R2017-04-12
03662663033039VFTVF9004RVF9004R2017-05-19
03662663033169VFTVF9105RVF9105R2017-05-19
03662663036863EasyspineES9038RES9038R2018-12-11
03662663037402InterBRIDGEIB9003RIB9003R2018-12-12
03662663041447ROI-TIR9098RIR9098R2018-12-12
03662663041676ROI-AIR9202RIR9202R2017-03-23
03662663043076ROI-AIR9431RIR9431R2018-12-12
03662663043083ROI-AIR9432RIR9432R2018-12-12
03662663043175ROI-CMC9002RMC9002R2017-03-23
03662663043182ROI-CMC9003RMC9003R2017-03-23
03662663043632MC+MC908RMC908R2018-12-11
03662663043656ROI-CMC9092RMC9092R2017-03-23
03662663043663ROI-CMC9093RMC9093R2017-03-23
03662663043670ROI-CMC9094RMC9094R2017-03-23
03662663044165MC+MC937RMC937R2018-12-11
03662663044172MC+MC938RMC938R2018-12-11
03662663044332MC+MC960RMC960R2018-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901035PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901615PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901622PrimusSPINAL ELEMENTS, INC.KWP2026-07-21