Integra® Compact Cranial Closure System

Basic Information

• Brand Name: Integra® Compact Cranial Closure System
• Primary DI: 10381780074359
• Version / Model: CRANCLOSIMP
• Catalog Number: CRANCLOSIMP
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Labeler DUNS: 963856096
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-15
• Public Version: 6
• Public Version Date: 2020-09-14
• Public Version Status: Update
• Public Device Record Key: 4fb533c3-48f3-4bed-bd91-0a2d7d32b9da
• Distribution End Date: 2020-09-12

Device Description

The Integra Compact Cranial Closer System bone plates and screws are made of pure titanium and titanium alloy with screw diameters from 1.5mm to 1.8mm and lengths from 3.0mm to 5.0mm. The system offers the operating room surgeon unique features and user friendly capabilities. This device is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
HBW	Fastener, Plate, Cranioplasty	Neurology	882.5360	2
GXR	Cover, Burr Hole	Neurology	882.5250	2
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	882.5320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46267	Cranioplasty plate, alterable	An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material (e.g., tantalum) that can be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M268CRANCLOSIMP1	HIBCC
Primary	10381780074359	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K112812	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10.16 in L x 4.41 in W x 2.0 in H