FDA.reportPublic FDA data

PathLoc-C Posterior Cervical Fixation System

Primary DI
08806344312500
Brand
PathLoc-C Posterior Cervical Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
6321-3514
Catalog number
6321-3514
Device description
PathLoc-C Cervical MIS Rod(Straight) 3.5x140mm 1EA
Published
2016-08-02
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
NKGOrthosis, Cervical Pedicle Screw Spinal Fixation

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
08806344312500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806344312500088063443125008806344312500

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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
00763000992521INFINITY OCT SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-09-26
00763000992552INFINITY OCT SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-09-26
07613327132359OASYSStryker CorporationNKG2015-12-04
07613327132366OASYSStryker CorporationNKG2015-12-04
04546540371508OASYSStryker CorporationNKG2015-09-14
04546540371553OASYSStryker CorporationNKG2015-09-14
04546540371560OASYSStryker CorporationNKG2015-09-14
04546540371577OASYSStryker CorporationNKG2015-09-14
04546540371584OASYSStryker CorporationNKG2015-09-14
04546540371591OASYSStryker CorporationNKG2015-09-14
04546540371607OASYSStryker CorporationNKG2015-09-14
04546540371614OASYSStryker CorporationNKG2015-09-14
04546540371621OASYSStryker CorporationNKG2015-09-14
04546540371638OASYSStryker CorporationNKG2015-09-14
04546540371645OASYSStryker CorporationNKG2015-09-14
04546540371652OASYSStryker CorporationNKG2015-09-14
04546540371669OASYSStryker CorporationNKG2015-09-14
04546540371676OASYSStryker CorporationNKG2015-09-14
04546540371683OASYSStryker CorporationNKG2015-09-14
04546540371690OASYSStryker CorporationNKG2015-09-14
04546540371706OASYSStryker CorporationNKG2015-09-14
04546540371713OASYSStryker CorporationNKG2015-09-14
04546540371720OASYSStryker CorporationNKG2015-09-14
04546540371737OASYSStryker CorporationNKG2015-09-14
04546540371744OASYSStryker CorporationNKG2015-09-14
04546540371751OASYSStryker CorporationNKG2015-09-14
04546540371768OASYSStryker CorporationNKG2015-09-14
04546540371775OASYSStryker CorporationNKG2015-09-14
04546540371782OASYSStryker CorporationNKG2015-09-14
04546540371799OASYSStryker CorporationNKG2015-09-14