Corin Metafix Hip Stem 340.436R

GUDID 05055196968462

Size 6 Femoral Broach

CORIN LTD

Orthopaedic broach

• Primary Device ID: 05055196968462
• NIH Device Record Key: eb0e29f4-994a-4875-85e6-2ff7a30d6b9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Corin Metafix Hip Stem
• Version Model Number: 340.436R
• Catalog Number: 340.436R
• 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	05055196968462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082525

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: false

[05055196968462]

Moist Heat or Steam 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 [Corin Metafix Hip Stem]

• 05055343897454: Curved Broach Handle
• 05055343897164: Distal Broach Size 3
• 05055343897157: Distal Broach Size 6
• 05055343897140: Distal Broach Size 5
• 05055343897133: Distal Broach Size 4
• 05055343897126: Distal Broach Size 2
• 05055343871508: Double Offset Handle (greatbatch)
• 05055343871485: Double Offset Handle (greatbatch)
• 05055343867464: Anterior Stem Impactor
• 05055343867426: Anterior Broach Handle
• 05055196971240: 040 Calcar Cutter (A/O) drive
• 05055196971233: 125 Standard Neck Trial
• 05055196971226: 135 Laterilized Neck Trial
• 05055196971219: 135 Standard Neck Trial
• 05055196968592: 3.00mm Allen Key
• 05055196968585: 2.5mm Allen key
• 05055196968509: Size 10 Femoral Broach
• 05055196968493: Size 9 Femoral Broach
• 05055196968486: Size 8 Femoral Broach
• 05055196968479: Size 7 Femoral Broach
• 05055196968462: Size 6 Femoral Broach
• 05055196968455: Size 5 Femoral Broach
• 05055196968448: Size 4 Femoral Broach
• 05055196968431: Size 3 Femoral Broach
• 05055196968424: Size 2 Femoral Broach
• 05055196968417: Size 1 Femoral Broach
• 05055196968400: Size 0 Femoral Broach
• 05055196968158: Metafix Size 6 Standard (125º)
• 05055196909496: Slap Hammer
• 05055196909373: Tapered IM Reamer
• 05055196909328: Femoral Punch
• 05055196909311: Femoral Tamp
• 05055196909298: Stem Introducer
• 05055196909267: Box Osteotome
• 05055196909243: Straight Stem Punch
• 05055196909236: Neck Resection Template
• 05055196900912: Metafix Size 10 Standard (125º)
• 05055196900905: Metafix Size 10 Lateralized (135º)
• 05055196900899: Metafix Size 10 Standard (135º)
• 05055196900882: Metafix Size 9 Standard (125º)
• 05055196900875: Metafix Size 9 Lateralized (135º)
• 05055196900868: Metafix Size 9 Standard (135º)
• 05055196900851: Metafix Size 8 Standard (125º)
• 05055196900844: Metafix Size 8 Lateralized (135º)
• 05055196900837: Metafix Size 8 Standard (135º)
• 05055196900820: Metafix Size 7 Standard (125º)
• 05055196900813: Metafix Size 7 Lateralized (135º)
• 05055196900806: Metafix Size 7 Standard (135º)
• 05055196900790: Metafix Size 6 Lateralized (135º)
• 05055196900783: Metafix Size 6 Standard (135º)