FDA.reportPublic FDA data

Femoral X-Ray Templates

Primary DI
00819251021210
Brand
Femoral X-Ray Templates
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
1312.00.000
Device description
Femoral X-Ray Templates
Published
2020-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTemplate
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819251021210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819251021210008192510212108192510212100819251021210

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify00The Klassic HD Hip System should be stored in a clean, dry location at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)486-6070udi@tjoinc.com

Regulatory Flags#

DUNS number
078416717
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094692940AP Sizer with Short LegsSRI-100502026-05-15
00810094692728CR Femoral Trial, Grit BlastedSRI-10051.012026-02-05
00810094692735CR Femoral Trial, Grit BlastedSRI-10051.022026-02-05
00810094692742CR Femoral Trial, Grit BlastedSRI-10051.032026-02-05
00810094692759CR Femoral Trial, Grit BlastedSRI-10051.042026-02-05
00810094692766CR Femoral Trial, Grit BlastedSRI-10051.052026-02-05
00810094692773CR Femoral Trial, Grit BlastedSRI-10051.062026-02-05
00810094692780CR Femoral Trial, Grit BlastedSRI-10051.072026-02-05
00810094692506Tibial Broach Impactor, Revision2904.00.0002025-05-14
00810094692278Universal Cone Impactor Head2021.12.0122025-04-24
00810094692285Universal Cone Impactor Head2021.34.0182025-04-24
00810094692292Universal Cone Impactor Head2021.57.0242025-04-24
00810094691950Universal Cone Impactor Head, Size 1, 12°2021.01.0122024-09-06
00810094691967Universa Cone Impactor Head, Size 2, 12°2021.02.0122024-09-06
00810094691974Universal Cone Impactor Head, Size 3, 18°2021.03.0182024-09-06
00810094691981Universal Cone Impactor Head, Size 4, 18°2021.04.0182024-09-06
00810094691998Universal Cone Impactor Head, Size 5, 24°2021.05.0242024-09-06
00810094692001Universal Cone Impactor Head, Size 6, 24°2021.06.0242024-09-06
00810094692018Universal Cone Impactor Head, Size 7, 24°2021.07.0242024-09-06
00819251021197Femoral Stem Impactor with Anteversion 1307.00.0002023-12-11

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