FDA.reportPublic FDA data

Easyspine

Primary DI
03662663002400
Brand
Easyspine
Company
LDR Spine Usa, Inc.
Model
ES1128T
Device description
Curved rod -R- L080mm
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
K123134000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123134000EASYSPINE SYSTEMLdr Spine USA, Inc.2013-02-01NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663002400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663002400036626630024003662663002400

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
Height5.6Millimeter
Length80Millimeter

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
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWP2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWP2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWP2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWP2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263080Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263080Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWP2026-06-02
00840311263080Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263097Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263097Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWP2026-06-02
00840311263097Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263103Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263103Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263103Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWP2026-06-02
00840311263110Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWP2026-06-02
00840311263110Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263110Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263127Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWP2026-06-02
00840311263127Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263127Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263134Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263134Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWP2026-06-02
00840311263134Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02