FDA.reportPublic FDA data

PathLoc-C Posterior Cervical Fixation System

Primary DI
08806344306752
Brand
PathLoc-C Posterior Cervical Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
6313-4014
Catalog number
6313-4014
Device description
PathLoc-C Cervical MIS Screw(Open Type, Sleeve 30mm) 4.0x14mm 1EA
Published
2016-07-27
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
08806344306752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806344306752088063443067528806344306752

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used 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 (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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
08809986491008BluEX Cervical Expandable Cage System1417-1000S2026-06-04
08809986491015BluEX Cervical Expandable Cage System1417-1100S2026-06-04
08809986491022BluEX Cervical Expandable Cage System1417-1200S2026-06-04
08809986491039BluEX Cervical Expandable Cage System1417-1300S2026-06-04
08809986491046BluEX Cervical Expandable Cage System1417-0407S2026-06-04
08809986491053BluEX Cervical Expandable Cage System1417-0507S2026-06-04
08809986491060BluEX Cervical Expandable Cage System1417-0607S2026-06-04
08809986491077BluEX Cervical Expandable Cage System1417-0707S2026-06-04
08809986491084BluEX Cervical Expandable Cage System1417-0807S2026-06-04
08809986491091BluEX Cervical Expandable Cage System1417-0907S2026-06-04
08809986491107BluEX Cervical Expandable Cage System1417-1007S2026-06-04
08809986491114BluEX Cervical Expandable Cage System1417-1107S2026-06-04
08809986491121BluEX Cervical Expandable Cage System1417-1207S2026-06-04
08809986491138BluEX Cervical Expandable Cage System1417-1307S2026-06-04
08809986491145CastleLoc-P Anterior Cervical Plate System6911-17152026-06-04
08809986491152CastleLoc-P Anterior Cervical Plate System6911-17172026-06-04
08809986491169CastleLoc-P Anterior Cervical Plate System6911-17192026-06-04
08809986491176CastleLoc-P Anterior Cervical Plate System6911-17212026-06-04
08809986491183CastleLoc-P Anterior Cervical Plate System6911-17232026-06-04
08809986491190CastleLoc-P Anterior Cervical Plate System6911-17252026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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