FDA.reportPublic FDA data

UNI-ELBOW

Primary DI
00886385026428
Brand
UNI-ELBOW
Company
Stryker GmbH
Model
410-5055
Catalog number
410-5055
Device description
Axis Locator Clamp, Location Cup
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JDBPROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDBProsthesis, Elbow, Semi-Constrained, CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886385026428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385026428008863850264288863850264280886385026428

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327605716PANGEA5422525422522026-06-02
07613327648331PANGEA5421605421602026-06-02
07613327648355PANGEA7039197039192026-06-02
07613327648362PANGEA5421615421612026-06-02
07613327648379PANGEA7039187039182026-06-02
37613153159729PROFYLE59-1204959-120492015-09-24
37613153159736PROFYLE59-1704959-170492015-06-24
37613153159743PROFYLE59-2304959-230492015-07-03
07613154583829PROFYLE59-12049E59-12049E2015-06-24
07613154583836PROFYLE59-17049E59-17049E2015-06-24
07613154583843PROFYLE59-23049E59-23049E2015-07-03
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846832012466Latitude™ - ElbowTORNIER, INC.JDB2022-03-31
93700386926603TEST-SALTO TALARISTORNIERJDB2019-12-23
08033390126465TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390126922TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128810TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128827TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128834TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128858TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128889TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138093TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138116TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138130TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138185TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138215TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138239TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138253TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138284TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138307TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138321TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138383TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138437TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138444TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138451TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138468TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138499TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138505TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138529TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138536TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138543TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138550TEMA ElbowLIMACORPORATE SPAJDB2019-05-24