Bone Filler Device

Basic Information

• Brand Name: Bone Filler Device
• Primary DI: 06938695537683
• Version / Model: FG2510
• Catalog Number: FG2510
• Company Name: Shanghai Kinetic Medical Co., Ltd.
• Labeler DUNS: 528198569
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-31
• Public Version: 1
• Public Version Date: 2020-06-08
• Public Version Status: New
• Public Device Record Key: 6e9359b2-f2f1-47c2-a630-4e38fa8883f7

Device Description

Bone Filler Device, Flat Tip, 9G (3.5mm)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRX	Arthroscope	Orthopedic	888.1100	2
NDN	Cement, Bone, Vertebroplasty	Orthopedic	888.3027	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47997	Bone grafting cannula	A rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06938695537683	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K113742	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	3.5	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: – 80 Percent (%) Relative Humidity