Paxeon BiPolar Head

Basic Information

• Brand Name: Paxeon BiPolar Head
• Primary DI: 08177570201969
• Version / Model: PR111-21-2856
• Company Name: PAXEON RECONSTRUCTION LLC
• Labeler DUNS: 080437990
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-14
• Public Version: 4
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: 63c06698-56c6-4a6a-908d-10edff8dc29b

Device Description

Bipolar Head Size 28/56

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	888.3390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33695	Bipolar femoral head outer component, hemiarthroplasty	An implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08177570201969	GS1

Premarket Submissions

Submission Number	Supplement Number
K133370	000