MANZA HA NON-CEMENTED CUP

Basic Information

• Brand Name: MANZA HA NON-CEMENTED CUP
• Primary DI: 00841176100657
• Version / Model: 101-00-062
• Catalog Number: 101-00-062
• Company Name: STINSON ORTHOPEDICS INC.
• Labeler DUNS: 080460688
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-26
• Public Version: 4
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: a44326e2-053c-4cce-87f1-b3224d7d1c4f

Device Description

MANZA HA NON-CEMENTED CUP NO HOLE, 62MM

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
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	888.3310	2
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate	Orthopedic	888.3353	2
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	888.3358	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43167	Acetabular shell	An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841176100657	GS1

Premarket Submissions

Submission Number	Supplement Number
K153131	000