BiOM T2

Basic Information

• Brand Name: BiOM T2
• Primary DI: B1551103S0
• Version / Model: 11-03S
• Company Name: BIONX MEDICAL TECHNOLOGIES, INC.
• Labeler DUNS: 788290471
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 00a028c7-707e-4a17-b845-071c9854ffa7

Device Description

BiOM T2 Silver (Ankle only)

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISW	Assembly, Knee/Shank/Ankle/Foot, External	Physical Medicine	890.3500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43569	Dynamic-response foot prosthesis	An artificial substitute for a foot designed as a component of an external lower-limb prosthesis to restore some of the appearance and/or function of the normal anatomy. It is available in a variety of designs (e.g., it may resemble the form of a natural foot, or have a split-toe design) and its construction is intended to enable the store and release of energy during the walking cycle to provide a sense of push-off and a more normal gait range. A dynamic-response foot is typically intended for an active and responsive patient to help increase activity level (e.g., vary walking speed, change direction quickly, walk long distances).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B1551103S0	HIBCC