FDA.reportPublic FDA data

CastleLoc Pectus Bar System

Primary DI
08809986482860
Brand
CastleLoc Pectus Bar System
Company
L&K BIOMED CO. ,LTD.
Model
OB28-0135
Device description
OB Pectus Bar - Straight
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
08809986482860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809986482860088099864828608809986482860

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
true
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
08809986479907LnK Spinal Instrument SystemCM0141-CC022026-05-12
08809986479914LnK Spinal Instrument SystemCM146-CS02-03012026-05-12
08809986479921LnK Spinal Instrument SystemCM146-CS02-03022026-05-12
08809986469991LnK Spinal Instrument SystemCM0142-PT012026-04-30
08809986489296LnK Spinal Instrument SystemLP01-07022026-04-29
08809986489302LnK Spinal Instrument SystemLP01-07042026-04-29
08809986489319LnK Spinal Instrument SystemLP01-07052026-04-29
08806344399808LnK Spinal Instrument SystemLS03-CM612026-04-16
08809986482815CastleLoc Pectus Bar SystemOB28-01102026-04-17
08809986482822CastleLoc Pectus Bar SystemOB28-01152026-04-17
08809986482839CastleLoc Pectus Bar SystemOB28-01202026-04-17
08809986482846CastleLoc Pectus Bar SystemOB28-01252026-04-17
08809986482853CastleLoc Pectus Bar SystemOB28-01302026-04-17
08809986469878LnK Spinal Instrument SystemBR05-00082026-04-16
08809986469885LnK Spinal Instrument SystemBR05-00092026-04-16
08809986479860LnK Spinal Instrument SystemBT01-90012026-04-16
08809986479877LnK Spinal Instrument SystemBT01-90022026-04-16
08809986479884LnK Spinal Instrument SystemBT01-90032026-04-16
08809986479891LnK Spinal Instrument SystemBT01-90042026-04-16
08809986488930BluEX-TM Lumbar Interbody Fusion Cage System JPT2211-0700S2026-04-15

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