FDA.reportPublic FDA data

LnK/OpenLoc-L Spinal Fixation System

Primary DI
08806344397125
Brand
LnK/OpenLoc-L Spinal Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
1043-0042
Device description
Crosslink 34-42mm
Published
2019-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183168000OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.2018-12-11NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806344397125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806344397125088063443971258806344397125

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
631159324
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986482501CastleLoc Pectus Bar SystemPF12-28122026-09-22
08809986482518CastleLoc Pectus Bar SystemPF12-28152026-09-22
08809986482525CastleLoc Pectus Bar SystemPF12-28182026-09-22
08809986482532CastleLoc Pectus Bar SystemPF12-28222026-09-22
08809986482549CastleLoc Pectus Bar SystemPF12-30182026-09-22
08809986482556CastleLoc Pectus Bar SystemPFB12-20122026-09-22
08809986482563CastleLoc Pectus Bar SystemPFB12-20152026-09-22
08809986482570CastleLoc Pectus Bar SystemPFB12-20182026-09-22
08809986482587CastleLoc Pectus Bar SystemPFB12-20222026-09-22
08809986493620LnK Spinal Instrument SystemTA29-20062026-09-21
08809986493637LnK Spinal Instrument SystemTA29-20092026-09-21
08809986493644LnK Spinal Instrument SystemTA29-20122026-09-21
08809986493651LnK Spinal Instrument SystemTA29-20152026-09-21
08809986493668LnK Spinal Instrument SystemTA29-25062026-09-21
08809986493675LnK Spinal Instrument SystemTA29-25092026-09-21
08809986493682LnK Spinal Instrument SystemTA29-25122026-09-21
08809986493699LnK Spinal Instrument SystemTA29-25152026-09-21
08809986493705LnK Spinal Instrument SystemTA29-30062026-09-21
08809986493712LnK Spinal Instrument SystemTA29-30092026-09-21
08809986493729LnK Spinal Instrument SystemTA29-30122026-09-21

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