Paxeon BiPolar Head

GUDID 08177570201877

Bipolar Head Size 28/47

PAXEON RECONSTRUCTION LLC

Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: 08177570201877
• NIH Device Record Key: 3ad8316b-5093-42c8-8e82-95dcae438085
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paxeon BiPolar Head
• Version Model Number: PR111-21-2847
• Company DUNS: 080437990
• Company Name: PAXEON RECONSTRUCTION LLC
• 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: true
• 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	08177570201877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133370

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2016-12-14

On-Brand Devices [Paxeon BiPolar Head]

• 08177570201990: Bipolar Head Size 28/59
• 08177570201983: Bipolar Head Size 28/58
• 08177570201976: Bipolar Head Size 28/57
• 08177570201969: Bipolar Head Size 28/56
• 08177570201952: Bipolar Head Size 28/55
• 08177570201945: Bipolar Head Size 28/54
• 08177570201938: Bipolar Head Size 28/53
• 08177570201921: Bipolar Head Size 28/52
• 08177570201914: Bipolar Head Size 28/51
• 08177570201907: Bipolar Head Size 28/50
• 08177570201891: Bipolar Head Size 28/49
• 08177570201884: Bipolar Head Size 28/48
• 08177570201877: Bipolar Head Size 28/47
• 08177570201860: Bipolar Head Size 28/46
• 08177570201853: Bipolar Head Size 28/45
• 08177570201846: Bipolar Head Size 28/44
• 08177570201839: Bipolar Head Size 28/43