C-STEM

Basic Information

• Brand Name: C-STEM
• Primary DI: 10603295235958
• Version / Model: 9612-21-000
• Catalog Number: 961221000
• Company Name: DEPUY INTERNATIONAL LTD
• Labeler DUNS: 896498813
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 4
• Public Version Date: 2024-02-08
• Public Version Status: Update
• Public Device Record Key: 9a21c162-0080-446a-afee-0302c69fd230

Device Description

C-STEM END CAP

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: 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
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	Orthopedic	888.3350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61271	Femoral stem centralizer	A small sterile implantable device intended to be used during the implantation of a cemented femoral stem prosthesis to centralize and stabilize the prosthesis tip within the femoral medullary canal; it is inserted into the medullary canal prior to cement insertion. It is made of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] and may have a winged structure.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10603295235958	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K982918	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: High: 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: High: 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: High: 30 Degrees Celsius