Cormet

Basic Information

• Brand Name: Cormet
• Primary DI: 05055196904668
• Version / Model: 479.042
• Catalog Number: 479.042
• Company Name: CORIN LTD
• Labeler DUNS: 295437313
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-10-14
• Public Version: 4
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: 13f14564-f43a-4a36-abfb-19036db1e5b6
• Distribution End Date: 2014-10-15

Device Description

Cormet resurfacing head - 42mm size 3 cemented

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 Conditional
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NXT	Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
33717	Resurfacing metallic hip prosthesis	An implantable partial substitute for a disease-damaged hip joint intended to replace the articulating surfaces of the hip while preserving the natural femoral head and neck. It consists of a metallic femoral cap component, that is placed over (resurfaces) a surgically-prepared femoral head, and a metallic acetabular component; that is, both components are supplied together. Fixation devices for implantation (e.g., screws/bolts) may be included and implantation may be performed with or without bone cement. This device is commonly used for younger/active patients to avoid total hip replacements/revisions.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055196904668	GS1

Premarket Submissions

Submission Number	Supplement Number
P050016	010