Symbionic Leg

Basic Information

• Brand Name: Symbionic Leg
• Primary DI: 05690967600679
• Version / Model: SBL13210
• Catalog Number: SBL13210
• 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: 2020-01-31
• Public Version Status: Update
• Public Device Record Key: 2394ebde-f557-4614-8e87-cae3c357175b
• Distribution End Date: 2018-07-31

Device Description

SYMBIONIC LEG 3 TRIAL 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
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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05690967600679	GS1

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 45 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius