TaperFit Cemented Hip System E922.440

GUDID 05055343885062

MODULAR HEAD TRIAL Ø40mm/-8/XS(12/14)

CORIN LTD

Femoral head prosthesis trial

• Primary Device ID: 05055343885062
• NIH Device Record Key: 17b8fdb5-3dee-4a5f-8c87-ddfc7a55728d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TaperFit Cemented Hip System
• Version Model Number: E922.440
• Catalog Number: E922.440
• Company DUNS: 295437313
• Company Name: CORIN LTD
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	05055343885062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142761

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[05055343885062]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-08-17

On-Brand Devices [TaperFit Cemented Hip System]

• 05055343892619: Size 4 50mm Offset Rasp
• 05055343892602: Size 3 50mm Offset Rasp
• 05055343892596: Size 2 50mm Offset Rasp
• 05055343892589: Size 1 50mm Offset Rasp
• 05055343892572: Size 0 50mm Offset Rasp
• 05055343892565: Size 4 45mm Offset Rasp
• 05055343892558: Size 3 45mm Offset Rasp
• 05055343892541: Size 2 45mm Offset Rasp
• 05055343892534: Size 1 45mm Offset Rasp
• 05055343892527: Size 0 45mm Offset Rasp
• 05055343892510: Size 4 38mm Offset Rasp
• 05055343892503: Size 3 38mm Offset Rasp
• 05055343892497: Size 2 38mm Offset Rasp
• 05055343892480: Size 1 38mm Offset Rasp
• 05055343892473: Size 0 38mm Offset Rasp
• 05055343892466: CDH Rasp
• 05055343892282: Cement Restrictor Introducer
• 05055343888056: FEMORAL CANAL OCCLUDER INTRODUCER
• 05055343885079: MODULAR HEAD TRIAL Ø28mm/+7/XL(12/14)
• 05055343885062: MODULAR HEAD TRIAL Ø40mm/-8/XS(12/14)
• 05055343885055: MODULAR HEAD TRIAL Ø36mm/-8/XS(12/14)
• 05055343885048: MODULAR HEAD TRIAL Ø32mm/-6/XS(12/14)
• 05055343885031: MODULAR HEAD TRIAL Ø28mm/-5/XS(12/14)
• 05055343883778: 8mm DISTAL DRILL
• 05055343883723: MODULAR BOX OSTEOTOME
• 05055343878439: STEM PUSHER
• 05055343871126: TaperFit Hip Stem 50mm Offset Large Stem size 4
• 05055343871119: TaperFit Hip Stem 50mm Offset Large Stem size 3
• 05055343871102: TaperFit Hip Stem 50mm Offset Large Stem size 2
• 05055343871096: TaperFit Hip Stem 50mm Offset Large Stem size 1
• 05055343871089: TaperFit Hip Stem 50mm Offset Large Stem size 0
• 05055343871072: TaperFit Hip Stem 45mm Offset Standard Stem size 0
• 05055343871065: TaperFit Hip Stem 38mm Offset Narrow Stem size 0
• 05055343871041: 50mm OFFSET RASP SIZE 4
• 05055343871034: 50mm OFFSET RASP SIZE 3
• 05055343871027: 50mm OFFSET RASP SIZE 2
• 05055343871010: 50mm OFFSET RASP SIZE 1
• 05055343871003: 50mm OFFSET RASP SIZE 0
• 05055343870990: 45mm OFFSET RASP SIZE 0
• 05055343870983: 38mm OFFSET RASP SIZE 0
• 05055343870174: Ø20/Ø22mm RESTRICTOR SIZER
• 05055343870167: Ø16/Ø18mm RESTRICTOR SIZER
• 05055343870150: Ø12/Ø14mm RESTRICTOR SIZER
• 05055343870143: Ø8/Ø10mm RESTRICTOR SIZER
• 05055343868843: TRIAL NECK
• 05055343868836: 45mm OFFSET RASP SIZE 4
• 05055343868829: 45mm OFFSET RASP SIZE 3
• 05055343868812: 45mm OFFSET RASP SIZE 2
• 05055343868805: 45mm OFFSET RASP SIZE 1
• 05055343868799: 38mm OFFSET RASP SIZE 4