FDA.reportPublic FDA data

RHEAD

Primary DI
00886385022802
Brand
RHEAD
Company
Stryker Trauma SA
Model
310-0013
Catalog number
310-0013
Device description
Lateral Assembly, Radial Head Implant, Size 4
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
00886385022802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385022802008863850228028863850228020886385022802

GMDN Terms#

Term, Definition table
TermDefinition
Elbow radius prosthesisA sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] or metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481999654
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327667738NASIT0006000SIT00060002025-03-28
07613327084191STEINMANN3593-1-0903593-1-0902025-01-09
07613327614633PANGEA5420045420042024-12-01
07613327624786PANGEA542110S542110S2024-12-01
07613327624809PANGEA5421125421122024-12-01
07613327624816PANGEA5421375421372024-12-01
07613327624830PANGEA5421855421852024-12-01
07613327624847PANGEA5421385421382024-12-01
07613327624861PANGEA5421185421182024-12-01
07613327624878PANGEA5421365421362024-12-01
07613327624885PANGEA5421195421192024-12-01
07613327624908PANGEA5421325421322024-12-01
07613327624915PANGEA542130S542130S2024-12-01
07613327624939PANGEA5421395421392024-12-01
07613327624977PANGEA5421725421722024-12-01
07613327624984PANGEA5421545421542024-12-01
07613327624991PANGEA5421205421202024-12-01
07613327625011PANGEA542132S542132S2024-12-01
07613327625028PANGEA5421135421132024-12-01
07613327625035PANGEA5421865421862024-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033390195225TEMA Elbow System LIMACORPORATE SPAJDB2024-07-26
08033390150934TEMA ElbowLIMACORPORATE SPAJDB2023-03-10
08033390150941TEMA ElbowLIMACORPORATE SPAJDB2023-03-10
08033390173186TEMA ElbowLIMACORPORATE SPAJDB2023-03-10
08033390173230TEMA ElbowLIMACORPORATE SPAJDB2023-03-10
08033390175449TEMA ElbowLIMACORPORATE SPAJDB2023-03-10
08033390175456TEMA ElbowLIMACORPORATE SPAJDB2023-03-10
08033390196802TEMA ElbowLIMACORPORATE SPAJDB2023-02-18
08033390196819TEMA ElbowLIMACORPORATE SPAJDB2023-02-18
08033390196826TEMA ElbowLIMACORPORATE SPAJDB2023-02-18
08033390196833TEMA ElbowLIMACORPORATE SPAJDB2023-02-18
08033390231435TEMA ElbowLIMACORPORATE SPAJDB2023-02-18
08033390231442TEMA ElbowLIMACORPORATE SPAJDB2023-02-18
08033390231459TEMA ElbowLIMACORPORATE SPAJDB2023-02-18
08033390126441TEMA ElbowLIMACORPORATE SPAJDB2023-01-25
00846832012459Latitude™ - ElbowTORNIER, INC.JDB2022-03-31
00846832012473Latitude™ - ElbowTORNIER, INC.JDB2022-03-31
08033390151252TEMA Elbow System LIMACORPORATE SPAJDB2021-11-27
08033390151269TEMA Elbow System LIMACORPORATE SPAJDB2021-11-27
08033390151276TEMA Elbow System LIMACORPORATE SPAJDB2021-11-27
08033390151283TEMA Elbow System LIMACORPORATE SPAJDB2021-11-27
08033390151290TEMA Elbow System LIMACORPORATE SPAJDB2021-11-27
08033390151306TEMA Elbow System LIMACORPORATE SPAJDB2021-11-27
08033390151313TEMA Elbow System LIMACORPORATE SPAJDB2021-11-27
08033390151320TEMA Elbow System LIMACORPORATE SPAJDB2021-11-27
08033390128865TEMA ElbowLIMACORPORATE SPAJDB2021-05-11
08033390128872TEMA ElbowLIMACORPORATE SPAJDB2021-05-11
00846832074693LATITUDE EV™TORNIER, INC.JDB2020-08-12
00846832074808LATITUDE EV™TORNIER, INC.JDB2020-08-12
08033390126434TEMA ElbowLIMACORPORATE SPAJDB2019-05-24