Metafix Hip Stem 579.0106

GUDID 05055343891261

Metafix Collared Size 6 Standard (135°)

CORIN LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 05055343891261
• NIH Device Record Key: b0cc9f23-e56b-4b94-be0e-ecd446b10dfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Metafix Hip Stem
• Version Model Number: 579.0106
• Catalog Number: 579.0106
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055343891261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153381

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-13

On-Brand Devices [Metafix Hip Stem]

• 05055343895627: ø40mm Calcar Cutter (Zimmer Drive)
• 05055343895610: ø50mm Calcar Cutter (Zimmer Drive)
• 05055343895603: ø45mm Calcar Cutter (Zimmer Drive)
• 05055343895597: ø50mm Calcar Cutter (Hudson Drive)
• 05055343895580: ø45mm Calcar Cutter (Hudson Drive)
• 05055343895573: ø40mm Calcar Cutter (Hudson Drive)
• 05055343895566: ø40mm Calcar Cutter (A/O Drive)
• 05055343895559: ø45mm Calcar Cutter (A/O Drive)
• 05055343895542: ø50mm Calcar Cutter (A/O Drive)
• 05055343894033: 125˚ Short Neck Trial
• 05055343894026: 135˚ Short Neck Trial
• 05055343891667: Size 10 Femoral Broach
• 05055343891650: Size 9 Femoral Broach
• 05055343891643: Size 8 Femoral Broach
• 05055343891636: Size 7 Femoral Broach
• 05055343891629: Size 6 Femoral Broach
• 05055343891612: Size 5 Femoral Broach
• 05055343891605: Size 4 Femoral Broach
• 05055343891599: Size 3 Femoral Broach
• 05055343891582: Size 2 Femoral Broach
• 05055343891575: Size 1 Femoral Broach
• 05055343891568: Size 0 Femoral Broach
• 05055343891476: Metafix Collared Size 9 Standard (125°)
• 05055343891469: Metafix Collared Size 8 Standard (125°)
• 05055343891452: Metafix Collared Size 2 Standard (125°)
• 05055343891445: Metafix Collared Size 7 Standard (125°)
• 05055343891438: Metafix Collared Size 6 Standard (125°)
• 05055343891421: Metafix Collared Size 5 Standard (125°)
• 05055343891414: Metafix Collared Size 4 Standard (125°)
• 05055343891407: Metafix Collared Size 3 Standard (125°)
• 05055343891360: Metafix Collared Size 2 Short Neck (125°)
• 05055343891339: Metafix Collared Size 2 Short Neck (135°)
• 05055343891315: Metafix Collared Size 1 Short Neck (135°)
• 05055343891292: Metafix Collared Size 9 Standard (135°)
• 05055343891285: Metafix Collared Size 8 Standard (135°)
• 05055343891278: Metafix Collared Size 7 Standard (135°)
• 05055343891261: Metafix Collared Size 6 Standard (135°)
• 05055343891254: Metafix Collared Size 5 Standard (135°)
• 05055343891247: Metafix Collared Size 4 Standard (135°)
• 05055343891230: Metafix Collared Size 3 Standard (135°)
• 05055343891223: Metafix Collared Size 2 Standard (135°)
• 05055343891216: Metafix Collared Size 1 Standard (135°)