Alliant Biotech

DI: G611WK110220 · Model: Size 5M · MEDISURGE LLC

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Product Codes

GMDN Terms

Identifiers

Pkg Device Count

Basic Information

Brand Name: Alliant Biotech
Primary DI: G611WK110220
Version / Model: Size 5M
Catalog Number: WK-1-1022
Company Name: MEDISURGE LLC
Labeler DUNS: 119198202
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2024-08-16
Public Version: 1
Public Version Date: 2024-08-26
Public Version Status: New
Public Device Record Key: 421f672b-fe43-4990-9f5e-c0a9f524565f

Device Description

Quatro-M Femoral Stem 5M

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: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: No
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
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	888.3358	2
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	888.3360	2
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	888.3353	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33181	Metal-on-polyethylene total hip prosthesis	A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Yes	Active
33581	Coated hip femur prosthesis, modular	A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Yes	Active
33715	Ceramic-on-polyethylene total hip prosthesis	A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a ceramic-on-polyethylene or cross-linked polyethylene (PE) interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Yes	Active