FDA.reportPublic FDA data

PathLoc- SI Joint Fusion System

Primary DI
08800061393965
Brand
PathLoc- SI Joint Fusion System
Company
L&K BIOMED CO. ,LTD.
Model
1025-8050
Catalog number
1025-8050
Device description
Locking Screw
Published
2023-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231841000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231841000PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.2023-07-14OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800061393965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800061393965088000613939658800061393965

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoatedAn implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
631159324
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986488718CastleLoc Pectus Bar System Instrument SetPB02-00012026-03-09
08809986488725CastleLoc Pectus Bar System Instrument SetPB01-00702026-03-09
08809986488732CastleLoc Pectus Bar System Instrument SetPB01-0003S2026-03-09
08809986488749CastleLoc Pectus Bar System Instrument SetPB01-08022026-03-09
08809986488756CastleLoc Pectus Bar System Instrument SetPB01-10022026-03-09
08809986488763CastleLoc Pectus Bar System Instrument SetPB01-12022026-03-09
08809986488770CastleLoc Pectus Bar System Instrument SetPB01-14022026-03-09
08809986488787CastleLoc Pectus Bar System Instrument SetPB01-16022026-03-09
08809986488794CastleLoc Pectus Bar System Instrument SetPB01-0069L2026-03-09
08809986488800CastleLoc Pectus Bar System Instrument SetPB01-0001S2026-03-09
08809986488817CastleLoc Pectus Bar System Instrument SetPB01-0001M2026-03-09
08809986488824CastleLoc Pectus Bar System Instrument SetPB01-0001L2026-03-09
08809986488831CastleLoc Pectus Bar System Instrument SetPB01-0002S2026-03-09
08809986488848CastleLoc Pectus Bar System Instrument SetPB01-0002M2026-03-09
08809986488855CastleLoc Pectus Bar System Instrument SetPB01-0002L2026-03-09
08809986488862CastleLoc Pectus Bar System Instrument SetPB02-0001S2026-03-09
08809986488879CastleLoc Pectus Bar System Instrument SetPB02-0001M2026-03-09
08809986488886CastleLoc Pectus Bar System Instrument SetPB02-0001L2026-03-09
08809986488893CastleLoc Pectus Bar System Instrument SetPB02-0002S2026-03-09
08809986488909CastleLoc Pectus Bar System Instrument SetPB02-0002M2026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841193127996T-FIX™3Dsi Joint Fusion SystemCutting Edge Spine, LLCOUR2026-03-24
00810131882082TiLink InSite Disposable KitSURGENTEC, LLCOUR2026-03-09
00810131882730Joint Fusion Office KitSURGENTEC, LLCOUR2026-03-09
00810131882204TiLink-P Instrument Removal Tool - MetalSURGENTEC, LLCOUR2026-02-25
00810055525768iFuse INTRA Ti ImplantSi-Bone Inc.OUR2026-02-17
00889929072189NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-02-10
M719GSIX122L0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX122S0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX1230SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX1240SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX1250SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX200L0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX200M0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX200S0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX200XL0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX201L0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX201S0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX2110SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX3000SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX3010SIros-XGenesys Orthopedics Systems LLCOUR2026-01-30
M719GSIX1131050SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1131150SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1150SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1160SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX117L0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX117S0SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1180SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1190550SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1190650SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27
M719GSIX1190750SIros-XGenesys Orthopedics Systems LLCOUR2026-01-27