FDA.report

Symbionic Leg

Primary DI
05690977431850
Brand
Symbionic Leg
Company
OSSUR AMERICAS, INC.
Model
SMBE4293
Catalog number
SMBE4293
Device description
KIT SYMBIONIC LEG 3 C4 S29 3Y
Published
2018-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ISWASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL

Product Code Classifications

CodeDeviceSpecialtyClass
ISWAssembly, Knee/Shank/Ankle/Foot, ExternalPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05690977431850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05690977431850056909774318505690977431850

GMDN Terms

TermDefinition
Knee-disarticulation prosthesisAn 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.

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius45 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
139280028
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05690967648749Power KneePKA10003PKA100032022-07-08
05690967642822Power KneePKA01001LPKA01001L2021-03-12
05690967642839Power KneePKA01001TPKA01001T2021-03-12
05690967648381Power KneePKA10001PKA100012021-03-12
05690967648404Power KneePKA10002PKA100022021-03-12
05690967567590Symbionic LegSBL12102SBL121022018-05-16
05690967600679Symbionic LegSBL13210SBL132102018-05-16
05690977223370Halo Systems505500V2505500V22019-02-08
05690977308626Halo Systems515400C515400C2019-02-08
05690977308633Halo Systems515500C515500C2019-02-08
05690977084254Halo Systems522C522C2018-05-16
05690977084469Halo Systems516TS516TS2018-05-16
05690977084490Halo Systems516DS516DS2018-05-16
05690977084544Halo Systems517CS517CS2018-05-16
05690977164093Halo Systems505300C505300C2018-05-16
05690977164116Halo Systems505400C505400C2018-05-16
05690977164130Halo Systems505500C505500C2018-05-16
05690977165335Halo Systems540C540C2018-05-16
05690977192348Halo Systems540V2540V22018-05-16
05690977192577Halo Systems517DS517DS2018-05-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860010894842Bio Leg™BIONICM INC.ISW2025-08-21
00860010894859Bio Leg™BIONICM INC.ISW2025-08-21
00860010894804Bio Leg™BIONICM INC.ISW2024-05-24
00860010894811Bio Leg™BIONICM INC.ISW2024-05-24
05690967648749Power KneeOSSUR AMERICAS, INC.ISW2022-07-08
05690967642822Power KneeOSSUR AMERICAS, INC.ISW2021-03-12
05690967642839Power KneeOSSUR AMERICAS, INC.ISW2021-03-12
05690967648381Power KneeOSSUR AMERICAS, INC.ISW2021-03-12
05690967648404Power KneeOSSUR AMERICAS, INC.ISW2021-03-12
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