Revision Femoral Head 5010.42.021

GUDID 08033390007054

Revision Femoral Head - Dia.28 mm S Taper 12/14

LIMACORPORATE SPA

Ceramic femoral head prosthesis

• Primary Device ID: 08033390007054
• NIH Device Record Key: 514c4d6a-72b7-4d8b-8238-93d612a61f14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revision Femoral Head
• Version Model Number: 5010.42.021
• Catalog Number: 5010.42.021
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390007054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243809

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-23
• Device Publish Date: 2025-04-15

On-Brand Devices [Revision Femoral Head]

• 08033390183840: Revision Femoral Head - Dia.40 mm XL Taper 12/14
• 08033390183833: Revision Femoral Head - Dia.40 mm L Taper 12/14
• 08033390183666: Revision Femoral Head - Dia.40 mm M Taper 12/14
• 08033390183642: Revision Femoral Head - Dia.40 mm S Taper 12/14
• 08033390183574: Revision Femoral Head - Dia.36 mm XL Taper 12/14
• 08033390183482: Revision Femoral Head - Dia.36 mm L Taper 12/14
• 08033390183475: Revision Femoral Head - Dia.36 mm M Taper 12/14
• 08033390183352: Revision Femoral Head - Dia.36 mm S Taper 12/14
• 08033390183314: Revision Femoral Head - Dia.32 mm L Taper 12/14
• 08033390183307: Revision Femoral Head - Dia.32 mm M Taper 12/14
• 08033390183291: Revision Femoral Head - Dia.32 mm S Taper 12/14
• 08033390183284: Revision Femoral Head - Dia.28 mm XL Taper 12/14
• 08033390183260: Revision Femoral Head - Dia.28 mm L Taper 12/14
• 08033390183253: Revision Femoral Head - Dia.28 mm M Taper 12/14
• 08033390183246: Revision Femoral Head - Dia.28 mm S Taper 12/14
• 08033390179898: Revision Femoral Head - Dia.32 mm XL Taper 12/14
• 08033390087940: Revision Femoral Head - Dia.40 mm XL Taper 12/14
• 08033390087933: Revision Femoral Head - Dia.40 mm L Taper 12/14
• 08033390087926: Revision Femoral Head - Dia.40 mm M Taper 12/14
• 08033390087919: Revision Femoral Head - Dia.40 mm S Taper 12/14
• 08033390007160: Revision Femoral Head - Dia.36 mm XL Taper 12/14
• 08033390007153: Revision Femoral Head - Dia.36 mm L Taper 12/14
• 08033390007146: Revision Femoral Head - Dia.36 mm M Taper 12/14
• 08033390007139: Revision Femoral Head - Dia.36 mm S Taper 12/14
• 08033390007122: Revision Femoral Head - Dia.32 mm XL Taper 12/14
• 08033390007115: Revision Femoral Head - Dia.32 mm L Taper 12/14
• 08033390007108: Revision Femoral Head - Dia.32 mm M Taper 12/14
• 08033390007092: Revision Femoral Head - Dia.32 mm S Taper 12/14
• 08033390007085: Revision Femoral Head - Dia.28 mm XL Taper 12/14
• 08033390007078: Revision Femoral Head - Dia.28 mm L Taper 12/14
• 08033390007061: Revision Femoral Head - Dia.28 mm M Taper 12/14
• 08033390007054: Revision Femoral Head - Dia.28 mm S Taper 12/14