Ensemble CMC

Basic Information

• Brand Name: Ensemble CMC
• Primary DI: 00810063560027
• Version / Model: Ensemble CMC Implant, Size 161
• Catalog Number: 101-CMC-161
• Company Name: Ensemble Orthopedics, Inc.
• Labeler DUNS: 004115364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-30
• Public Version: 1
• Public Version Date: 2021-04-07
• Public Version Status: New
• Public Device Record Key: 6f271ff4-9e18-45cd-8eee-092e1a16ed49

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
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	888.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40126	Metacarpal prosthesis	A sterile implantable device designed to replace the proximal end (base) of the first metacarpal of the thumb carpometacarpal (CMC) joint (articulation with the trapezium) typically to treat thumb instability/motion disabilities caused by arthritis or fracture. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal); implantation may be performed with our without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810063560027	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K201072	000