CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS)

Basic Information

• Brand Name: CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS)
• Primary DI: 04717002404175
• Version / Model: 9903.0101.15S
• Catalog Number: 9903.0101.15S
• Company Name: OSSAWARE BIOTECH CO., LTD.
• Labeler DUNS: 656747172
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-28
• Public Version: 4
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: ea4a5e4b-8dd6-460c-8140-bd466a0d57da

Device Description

CUSMED Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile (3 PCS)

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
GXR	Cover, Burr Hole	Neurology	882.5250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56730	Cranial bone flap fixation clip	A sterile, non-metallic, non-bioabsorbable device designed to be partially implanted around the perimeter of a replaced cranial bone flap after a craniotomy to ensure structural stability during the healing period. It is typically made of biocompatible plastic materials [e.g., polyoxymethylene (POM), commonly known as Delrin] and is typically designed with internal and external flanges that are tensioned together over the bone of both the flap and skull and locked via a central stem. It may also be used for craniofacial bone fracture fixation. Its non-metallic design makes it more compatible with radiological imaging than metallic clips.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14717002404172	GS1	Delivery box	4	In Commercial Distribution
Primary	04717002404175	GS1
Package	24717002404179	GS1	Shipping carton	16	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192310	000