FDA.report

Latitude™ EV

Primary DI
00846832002863
Brand
Latitude™ EV
Company
TORNIER, INC.
Model
0030503
Published
2015-10-16
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

Related Records

Contact Domains

Product Codes

CodeName
JDBPROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Product Code Classifications

CodeDeviceSpecialtyClass
JDBProsthesis, Elbow, Semi-Constrained, CementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846832002863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832002863008468320028638468320028630846832002863

GMDN Terms

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length83Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)494-7950customerservice@tornier.com

Regulatory Flags

DUNS number
968990812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00846832077632PERFORM™ HUMERAL SYSTEMDWR13602020-11-10
00846832077649PERFORM™ HUMERAL SYSTEMDWR13632020-11-10
00846832077656PERFORM™ HUMERAL SYSTEMDWR13662020-11-10
00846832077663PERFORM™ HUMERAL SYSTEMDWR13902020-11-10
00846832077670PERFORM™ HUMERAL SYSTEMDWR13932020-11-10
00846832077687PERFORM™ HUMERAL SYSTEMDWR13962020-11-10
00846832077694PERFORM™ HUMERAL SYSTEMDWR23602020-11-10
00846832077700PERFORM™ HUMERAL SYSTEMDWR23632020-11-10
00846832077717PERFORM™ HUMERAL SYSTEMDWR23662020-11-10
00846832077724PERFORM™ HUMERAL SYSTEMDWR23902020-11-10
00846832077731PERFORM™ HUMERAL SYSTEMDWR23932020-11-10
00846832077748PERFORM™ HUMERAL SYSTEMDWR23962020-11-10
00846832077755PERFORM™ HUMERAL SYSTEMDWR24202020-11-10
00846832077762PERFORM™ HUMERAL SYSTEMDWR24232020-11-10
00846832077779PERFORM™ HUMERAL SYSTEMDWR24262020-11-10
00846832077786PERFORM™ HUMERAL SYSTEMDWR33302020-11-10
00846832077793PERFORM™ HUMERAL SYSTEMDWR33332020-11-10
00846832077809PERFORM™ HUMERAL SYSTEMDWR33362020-11-10
00846832077816PERFORM™ HUMERAL SYSTEMDWR33602020-11-10
00846832077823PERFORM™ HUMERAL SYSTEMDWR33632020-11-10

Other Devices Sharing Product Codes

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