CastleLoc Pectus Bar System

Basic Information

• Brand Name: CastleLoc Pectus Bar System
• Primary DI: 08809986482204
• Version / Model: PB12-0019
• Company Name: L&K BIOMED CO. ,LTD.
• Labeler DUNS: 631159324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-30
• Public Version: 1
• Public Version Date: 2025-06-09
• Public Version Status: New
• Public Device Record Key: e3ce7cdc-65ae-4f6c-b573-dc66efd511fc

Device Description

Stabilizer – Bridge 1 (type1)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRS	Plate, Fixation, Bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58340	Rib/rib cage internal fixation/bracing system bracing bar	A non-sterile implantable device intended to be used with rib grip/anchor implants either for internal fixation of a fracture or to bridge a deficit in the rib cage. It is typically a thin bar (approximately 20 cm long), with or without serrations, made of metal [e.g., titanium (Ti)]. It can be surgically removed when required or remain in situ. This device must be sterilized prior to use.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809986482204	GS1

Premarket Submissions

Submission Number	Supplement Number
K243357	000