TriFit TS Blade Stem

Basic Information

• Brand Name: TriFit TS Blade Stem
• Primary DI: 05055343885451
• Version / Model: 695.571
• Catalog Number: 695.571
• Company Name: CORIN LTD
• Labeler DUNS: 295437313
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-17
• Public Version: 5
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: c30ab3ca-de85-4874-b8e5-a3cea5e82568

Device Description

NECK TRIAL - LATERALISED

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: 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: 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
KWL	Prosthesis, hip, hemi-, femoral, metal	Orthopedic	888.3360	2
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate	Orthopedic	888.3353	2
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	Orthopedic	888.3353	2
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	Orthopedic	888.3390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58481	Femoral stem prosthesis trial	A copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055343885451	GS1

Customer Contacts

• Phone: [phone] ext. 2203
• Email: [email protected]
• Phone: [phone] ext. 2118
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K121563	000