Symbionic Leg

Basic Information

• Brand Name: Symbionic Leg
• Primary DI: 05690967567590
• Version / Model: SBL12102
• Catalog Number: SBL12102
• Company Name: OSSUR AMERICAS, INC.
• Labeler DUNS: 139280028
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-16
• Public Version: 2
• Public Version Date: 2020-02-12
• Public Version Status: Update
• Public Device Record Key: ef546ed9-bceb-4086-88b5-4490166ff8b4
• Distribution End Date: 2018-07-31

Device Description

SYMBIONIC LEG LOANER 25-30

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: Yes
• 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
41541	Knee-disarticulation prosthesis	An artificial substitute for a disarticulation amputation at the knee joint, or used in cases of limb deficiency at birth, 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 typically made of metal and plastic and is typically constructed as a polycentric hinge that incorporates an upper joint section that fits against a full-length prosthetic femur. It is typically spring-assisted to control the swing of the leg.	No	Obsolete
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	05690967567590	GS1