FDA.reportPublic FDA data

CastleLoc Pectus Bar System

Primary DI
08809986482761
Brand
CastleLoc Pectus Bar System
Company
L&K BIOMED CO. ,LTD.
Model
OB28-0085
Device description
CastleLoc Pectus Straight Circular Bar
Published
2025-07-18
Public version status
Update
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
08809986482761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809986482761088099864827618809986482761

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
08809986489807LnK Spinal Instrument SystemCC10-00112026-10-19
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
08809986482860CastleLoc Pectus Bar SystemOB28-01352026-04-17
08809986482778CastleLoc Pectus Bar SystemOB28-00902025-07-21
08809986482785CastleLoc Pectus Bar SystemOB28-00952025-07-21
08809986482716CastleLoc Pectus Bar SystemOB28-00602025-07-18
08809986482723CastleLoc Pectus Bar SystemOB28-00652025-07-18
08809986482730CastleLoc Pectus Bar SystemOB28-00702025-07-18
08809986482747CastleLoc Pectus Bar SystemOB28-00752025-07-18
08809986482754CastleLoc Pectus Bar SystemOB28-00802025-07-18
08809986489753LnK Spinal Instrument SystemPT01-00032026-10-08
08809986489760LnK Spinal Instrument SystemPT01-00042026-10-08
08809986489777LnK Spinal Instrument SystemPT01-00092026-10-08
08809986489784LnK Spinal Instrument SystemPT01-02152026-10-08
08809986489791LnK Spinal Instrument SystemPT01-02162026-10-08
08809986482501CastleLoc Pectus Bar SystemPF12-28122026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810136433593OptimalMTP®Forma Medical, Inc.HRS2026-10-16
00810136433609OptimalMTP®Forma Medical, Inc.HRS2026-10-16
05055662976649Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976656Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976663Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976670Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976687Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
03700569631840Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569631857Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
00888118131867LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.HRS2026-04-23
00888118132529LEVEL ONE EXTREMITYKLS-Martin L.P.HRS2026-04-23
08809986482815CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482822CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482839CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482846CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482853CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482860CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-04-17
08809986482778CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-21
08809986482785CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-21
08809986482716CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482723CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482730CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482747CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
08809986482754CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2025-07-18
00810112599268TriLEAPCROSSROADS EXTREMITY SYSTEMSHRS2025-03-17
00810112593341TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHRS2024-02-22
00885556838211Total Foot System 2Smith & Nephew, Inc.HRS2023-04-18
B562PKSMC0835NSLTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, LeftWishbone Medical, Inc.HRS2019-09-06
B562PKSMC0835NSRTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, RightWishbone Medical, Inc.HRS2019-09-06
00842188115424Radial Shortening PlateTrimed, INC.HRS2017-05-19