FDA.reportPublic FDA data

PathLoc-C Posterior Cervical Fixation System

Primary DI
08806344307803
Brand
PathLoc-C Posterior Cervical Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
6316-3514
Device description
PathLoc-C Cervical MIS Screw(Open Type, Sleeve 60mm) 3.5x14mm 1EA
Published
2020-06-15
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
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153439000PathLoc-C Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.2016-07-21NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806344307803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806344307803088063443078038806344307803

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

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
08800322693100VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693117VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693124VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693131VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693148VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693155VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693162VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693179VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693186VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693193VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693209VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693216VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693223VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693230VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693247VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693254VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693261VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693278VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693285VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693292VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693308VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693315VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693322VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693339VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693346VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693353VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693360VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693377VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693384VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693391VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30