FDA.reportPublic FDA data

PathLoc-C Posterior Cervical Fixation System

Primary DI
08806344312739
Brand
PathLoc-C Posterior Cervical Fixation System
Company
L&K BIOMED CO. ,LTD.
Model
6103-7037
Catalog number
6103-7037
Device description
PathLoc-C Cervical MIS Set Screw 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
08806344312739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806344312739088063443127398806344312739

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone set screwA small, threaded, implantable, non-bioabsorbable disc intended to be threaded into the proximal end of a spinal bone screw (screw head), anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

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
08809986482440CastleLoc Pectus Bar SystemPF12-20222026-08-25
08809986482457CastleLoc Pectus Bar SystemPF12-23122026-08-25
08809986482464CastleLoc Pectus Bar SystemPF12-23152026-08-25
08809986482471CastleLoc Pectus Bar SystemPF12-23182026-08-25
08809986482488CastleLoc Pectus Bar SystemPF12-23222026-08-25
08809986482495CastleLoc Pectus Bar SystemPF12-25182026-08-25
08809986481894CastleLoc Pectus Bar SystemPB25-E1602026-08-21
08809986481900CastleLoc Pectus Bar SystemPB25-E1652026-08-21
08809986481917CastleLoc Pectus Bar SystemPB25-E1702026-08-21
08809986481924CastleLoc Pectus Bar SystemPB10-00032026-08-21
08809986481931CastleLoc Pectus Bar SystemPB10-00072026-08-21
08809986481948CastleLoc Pectus Bar SystemPB10-00082026-08-21
08809986481955CastleLoc Pectus Bar SystemPB10-00092026-08-21
08809986481962CastleLoc Pectus Bar SystemPB10-00102026-08-21
08809986481979CastleLoc Pectus Bar SystemPB10-00112026-08-21
08809986481986CastleLoc Pectus Bar SystemPB10-00122026-08-21
08809986481993CastleLoc Pectus Bar SystemPB10-00132026-08-21
08809986482006CastleLoc Pectus Bar SystemPB10-00142026-08-21
08809986482013CastleLoc Pectus Bar SystemPB10-00152026-08-21
08809986482020CastleLoc Pectus Bar SystemPB10-00162026-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982521134QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521141QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521158QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521165QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521172QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521189QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521196QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521202QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521219QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521226QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521233QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521240QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521257QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521264QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521271QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368611QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368628QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368635QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368642QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00840606193382Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193399Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193405Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193412Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193429Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193436Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193443Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193450Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194044Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194051Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194068Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30