TriFit TS Blade Stem 694.1002

GUDID 05055343877067

TriFit TS Tapered Stem Lateralised Size 2

CORIN LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 05055343877067
• NIH Device Record Key: 9d7e0568-2be5-4841-8501-4b4876fc8f8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriFit TS Blade Stem
• Version Model Number: 694.1002
• Catalog Number: 694.1002
• Company DUNS: 295437313
• Company Name: CORIN LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055343877067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121563

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[05055343877067]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

On-Brand Devices [TriFit TS Blade Stem]

• 05056139231452: Kinked Stem Introducer
• 05055343899564: Driven corkscrew
• 05055343899533: DAA Straight Impaction handle
• 05055343899175: DAA Woodpecker Impaction handle
• 05055343897966: DAA Impaction Handle
• 05055343897652: DAA Box Osteotome
• 05055343889930: Single Offset Handle
• 05055343888360: DOUBLE OFFSET IMPACTION HANDLE (LEFT)
• 05055343888353: DOUBLE OFFSET IMPACTION HANDLE (RIGHT)
• 05055343885543: Ø50 CALCAR CUTTER (ZIMMER DRIVE)
• 05055343885536: Ø40 CALCAR CUTTER (ZIMMER DRIVE)
• 05055343885529: Ø50 CALCAR CUTTER (HUDSON DRIVE)
• 05055343885512: Ø40 CALCAR CUTTER (HUDSON DRIVE)
• 05055343885505: CALCAR CUTTER 50mm AO DRIVE
• 05055343885499: CALCAR CUTTER 40mm AO DRIVE
• 05055343885482: NON-THREADED INTRODUCER
• 05055343885475: STRAIGHT 'LAZY-S' IMPACTION HANDLE
• 05055343885468: THREADED INTRODUCER
• 05055343885451: NECK TRIAL - LATERALISED
• 05055343885444: NECK TRIAL - STANDARD
• 05055343885437: STRAIGHT IMPACTION HANDLE
• 05055343884249: RASP SIZE 11
• 05055343884232: RASP SIZE 10
• 05055343884225: EASP SIZE 9
• 05055343884218: RASP SIZE 8
• 05055343884201: RASP SIZE 7
• 05055343884195: RASP SIZE 6
• 05055343884188: RASP SIZE 5
• 05055343884171: RASP SIZE 4
• 05055343884164: RASP SIZE 3
• 05055343884157: RASP SIZE 2
• 05055343884140: RASP SIZE 1
• 05055343884133: STARTER RASP
• 05055343884126: DOUBLE OFFSET IMPACTION HANDLE (LEFT)
• 05055343884119: DOUBLE OFFSET IMPACTION HANDLE (RIGHT)
• 05055343880142: EXTRACTION ROD
• 05055343880135: SLOTTED MALLET
• 05055343877340: T-HANDLE REAMER
• 05055343877265: TriFit TS Tapered Stem Standard Size 10
• 05055343877258: TriFit TS Tapered Stem Standard Size 9
• 05055343877241: TriFit TS Tapered Stem Standard Size 8
• 05055343877234: TriFit TS Tapered Stem Standard Size 7
• 05055343877227: TriFit TS Tapered Stem Standard Size 6
• 05055343877210: TriFit TS Tapered Stem Standard Size 5
• 05055343877203: TriFit TS Tapered Stem Standard Size 4
• 05055343877197: TriFit TS Tapered Stem Standard Size 3
• 05055343877180: TriFit TS Tapered Stem Standard Size 2
• 05055343877173: TriFit TS Tapered Stem Standard Size 1
• 05055343877166: TriFit TS Tapered Stem Standard Size 11
• 05055343877159: TriFit TS Tapered Stem Lateralised Size 11