CALCANEA

Basic Information

• Brand Name: CALCANEA
• Primary DI: 10381780048367
• Version / Model: 180320ND
• Catalog Number: 180320ND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 4
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: a2c9c7a0-c56b-4cdf-ba3d-674e95ca8c52
• Distribution End Date: 2017-01-01

Device Description

The CALCANEA locking screws are dedicated for the fixation of the CALCANEA Plate. They are made out of Titanium alloy and delivered non sterile. They are threaded heads adapted to the threaded holes of the plate. The range of screws include only one diameter of 3.5mm and a length from 20mm to 45mm (by 5mm). The fixation screws are self tapping, with a smooth tip to protect soft tissues. The screw head design enables a low profile screw/plate/bone interface.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
56642	Orthopaedic bone screw, non-bioabsorbable, non-sterile	A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M248180320ND1	HIBCC
Primary	10381780048367	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K041786	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3.5mm diam. x 20mm length

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dry place.