FDA.reportPublic FDA data

CastleLoc Pectus Bar System

Primary DI
08809986482983
Brand
CastleLoc Pectus Bar System
Company
L&K BIOMED CO. ,LTD.
Model
OB28-0195
Device description
CastleLoc Pectus Straight Circular Bar
Published
2026-10-26
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
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809986482983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809986482983088099864829838809986482983

GMDN Terms#

Term, Definition table
TermDefinition
Funnel chest remodelling barA non-sterile implantable device intended to be used to reduce the deformity of pectus excavatum (funnel chest) by applying outward force from a position deep to the sternum to reposition the sternum; it is typically used in paediatric patients and surgically removed when remodelling is evident (after 2-3 years). It is a thin curved bar, with or without serrations, made of metal [e.g., stainless steel, titanium (Ti)] that can be anchored with wires or with stabilizer plates laterally on the rib cage. This is a single-patient device intended to be sterilized prior to use.

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
08809986482600CastleLoc Pectus Bar SystemPFB12-23152026-10-26
08809986482617CastleLoc Pectus Bar SystemPFB12-23182026-10-26
08809986482624CastleLoc Pectus Bar SystemPFB12-23222026-10-26
08809986482631CastleLoc Pectus Bar SystemPFB12-25182026-10-26
08809986482648CastleLoc Pectus Bar SystemPFB12-28122026-10-26
08809986482655CastleLoc Pectus Bar SystemPFB12-28152026-10-26
08809986482662CastleLoc Pectus Bar SystemPFB12-28182026-10-26
08809986482679CastleLoc Pectus Bar SystemPFB12-28222026-10-26
08809986482686CastleLoc Pectus Bar SystemPFB12-30182026-10-26
08809986482792CastleLoc Pectus Bar SystemOB28-01002026-10-26
08809986482808CastleLoc Pectus Bar SystemOB28-01052026-10-26
08809986482877CastleLoc Pectus Bar SystemOB28-01402026-10-26
08809986482884CastleLoc Pectus Bar SystemOB28-01452026-10-26
08809986482891CastleLoc Pectus Bar SystemOB28-01502026-10-26
08809986482907CastleLoc Pectus Bar SystemOB28-01552026-10-26
08809986482914CastleLoc Pectus Bar SystemOB28-01602026-10-26
08809986482921CastleLoc Pectus Bar SystemOB28-01652026-10-26
08809986482938CastleLoc Pectus Bar SystemOB28-01702026-10-26
08809986482945CastleLoc Pectus Bar SystemOB28-01752026-10-26
08809986482952CastleLoc Pectus Bar SystemOB28-01802026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986482600CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482617CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482624CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482631CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482648CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482655CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482662CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482679CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482686CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482792CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482808CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482877CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482884CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482891CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482907CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482914CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482921CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482952CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482969CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482976CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482990CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986483027CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986483034CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986483041CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482594CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-23
00810112599275TriLEAPSynthes GmbHHRS2025-03-20
00810112599169TriLEAPSynthes GmbHHRS2025-03-18
00810112599176TriLEAPSynthes GmbHHRS2025-03-17