FDA.reportPublic FDA data

LnK Posterior Cervical Fixation System

Primary DI
08806344304819
Brand
LnK Posterior Cervical Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
6135-3580
Catalog number
6135-3580
Device description
L&K Biomed Cervical Right Offset Semi Reduction Hook 8.0mm 1EA
Published
2015-09-22
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
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143278000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143278000LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.2015-07-29KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806344304819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806344304819088063443048198806344304819

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
08809986489814LnK Spinal Instrument SystemCM138-XTP01-185506062026-11-05
08809986489821LnK Spinal Instrument SystemCM138-XTP01-185508062026-11-05
08809986489838LnK Spinal Instrument SystemCM138-XTP01-185510062026-11-05
08809986489845LnK Spinal Instrument SystemXTP01-18550606C012026-11-05
08809986489852LnK Spinal Instrument SystemXTP01-18550806C012026-11-05
08809986489869LnK Spinal Instrument SystemXTP01-18551006C012026-11-05
08809986489876LnK Spinal Instrument SystemLC04-1207SC022026-11-05
08809986489883LnK Spinal Instrument SystemLC04-1207SC032026-11-05
08809986489890LnK Spinal Instrument SystemLC04-1207SC042026-11-05
08809986489906LnK Spinal Instrument SystemLP01-0603C012026-11-05
08809986487339CastleLoc Pectus Bar SystemBC05-014092025-10-29
08809986487360CastleLoc Pectus Bar SystemBC05-01752025-10-24
08809986485137CastleLoc Pectus Bar SystemOB30-91852026-10-29
08809986485144CastleLoc Pectus Bar SystemOB30-91902026-10-29
08809986485151CastleLoc Pectus Bar SystemOB30-91952026-10-29
08809986485168CastleLoc Pectus Bar SystemOB30-92002026-10-29
08809986485274CastleLoc Pectus Bar SystemWB28-61002026-10-29
08809986485281CastleLoc Pectus Bar SystemWB28-61052026-10-29
08809986485298CastleLoc Pectus Bar SystemWB28-61102026-10-29
08809986485304CastleLoc Pectus Bar SystemWB28-61152026-10-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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