Endohead

GUDID 07630030806636

Medacta Endo Head Ø 54, M

Medacta International SA

Femoral head bipolar component Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: 07630030806636
• NIH Device Record Key: a5fede8b-3c17-472b-bc2d-1641f3654da7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endohead
• Version Model Number: 01.25.254M
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07630030806636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111145

FDA Product Code

• LZY: Prosthesis, Hip, Hemi-, Femoral, Metal Ball

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: 2014-11-18

On-Brand Devices [Endohead]

• 07630030806704: Medacta Endo Head Ø 56, S
• 07630030806698: Medacta Endo Head Ø 56, M
• 07630030806681: Medacta Endo Head Ø 56, L
• 07630030806674: Medacta Endo Head Ø 55, S
• 07630030806667: Medacta Endo Head Ø 55, M
• 07630030806650: Medacta Endo Head Ø 55, L
• 07630030806643: Medacta Endo Head Ø 54, S
• 07630030806636: Medacta Endo Head Ø 54, M
• 07630030806629: Medacta Endo Head Ø 54, L
• 07630030806612: Medacta Endo Head Ø 53, S
• 07630030806605: Medacta Endo Head Ø 53, M
• 07630030806599: Medacta Endo Head Ø 53, L
• 07630030806582: Medacta Endo Head Ø 52, S
• 07630030806575: Medacta Endo Head Ø 52, M
• 07630030806568: Medacta Endo Head Ø 52, L
• 07630030806551: Medacta Endo Head Ø 51, S
• 07630030806544: Medacta Endo Head Ø 51, M
• 07630030806537: Medacta Endo Head Ø 51, L
• 07630030806520: Medacta Endo Head Ø 50, S
• 07630030806513: Medacta Endo Head Ø 50, M
• 07630030806506: Medacta Endo Head Ø 50, L
• 07630030806490: Medacta Endo Head Ø 49, S
• 07630030806483: Medacta Endo Head Ø 49, M
• 07630030806476: Medacta Endo Head Ø 49, L
• 07630030806469: Medacta Endo Head Ø 48, S
• 07630030806452: Medacta Endo Head Ø 48, M
• 07630030806445: Medacta Endo Head Ø 48, L
• 07630030806438: Medacta Endo Head Ø 47, S
• 07630030806421: Medacta Endo Head Ø 47, M
• 07630030806414: Medacta Endo Head Ø 47, L
• 07630030806407: Medacta Endo Head Ø 46, S
• 07630030806391: Medacta Endo Head Ø 46, M
• 07630030806384: Medacta Endo Head Ø 46, L
• 07630030806377: Medacta Endo Head Ø 45, S
• 07630030806360: Medacta Endo Head Ø 45, M
• 07630030806353: Medacta Endo Head Ø 45, L
• 07630030806346: Medacta Endo Head Ø 44, S
• 07630030806339: Medacta Endo Head Ø 44, M
• 07630030806322: Medacta Endo Head Ø 44, L
• 07630030806315: Medacta Endo Head Ø 43, S
• 07630030806308: Medacta Endo Head Ø 43, M
• 07630030806292: Medacta Endo Head Ø 43, L
• 07630030806285: Medacta Endo Head Ø 42, S
• 07630030806278: Medacta Endo Head Ø 42, M
• 07630030806261: Medacta Endo Head Ø 42, L
• 07630030806254: Medacta Endo Head Ø 41, S
• 07630030806247: Medacta Endo Head Ø 41, M
• 07630030806230: Medacta Endo Head Ø 41, L
• 07630030806223: Medacta Endo Head Ø 40, S
• 07630030806216: Medacta Endo Head Ø 40, M