FDA.reportPublic FDA data

"""LnK Posterior Cervical Fixation System/ CastleLoc-S Posterior Cervical Fixation"

Primary DI
08809986479402
Brand
"""LnK Posterior Cervical Fixation System/ CastleLoc-S Posterior Cervical Fixation"
Company
L&K BIOMED CO. ,LTD.
Model
6118-5544
Device description
Partially Semi Poly Screw 5.5X44mm
Published
2025-04-10
Public version status
New
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
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200793000LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.2020-10-08NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809986479402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809986479402088099864794028809986479402

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606186544OMEGA XPSPINAL ELEMENTS, INC.KWP2026-09-22
00840606186551OMEGA XPSPINAL ELEMENTS, INC.KWP2026-09-22
00613994738646ZEPHIR® Anterior Cervical SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2019-03-07
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
04546540147257XIA IIStryker CorporationKWP2014-12-08
04546540147769XIA IIStryker CorporationKWP2014-12-08
04546540147806XIA IIStryker CorporationKWP2014-12-08
04546540147905XIA IIStryker CorporationKWP2014-12-08
04546540147912XIA IStryker CorporationKWP2014-12-08
04546540147929XIA IStryker CorporationKWP2014-12-08
04546540147936XIA IStryker CorporationKWP2014-12-08
04546540147974XIA IStryker CorporationKWP2014-12-08
04546540147981XIA IStryker CorporationKWP2014-12-08
04546540147998XIA IStryker CorporationKWP2014-12-08
04546540148001XIA IIStryker CorporationKWP2014-12-08
04546540148018XIA IIStryker CorporationKWP2014-12-08
04546540148025XIA IIStryker CorporationKWP2014-12-08
04546540148735XIA IIStryker CorporationKWP2014-12-08
04546540148742XIA IIStryker CorporationKWP2014-12-08
04546540148759XIA IIStryker CorporationKWP2014-12-08
04546540148766XIA IIStryker CorporationKWP2014-12-08
04546540148773XIA IIStryker CorporationKWP2014-12-08
04546540148780XIA IIStryker CorporationKWP2014-12-08
04546540148797XIA IIStryker CorporationKWP2014-12-08
04546540148803XIA IIStryker CorporationKWP2014-12-08
04546540148810XIA IIStryker CorporationKWP2014-12-08