FDA.report

Platform Hooded Acetabular Insert Trial

Primary DI
00810094690052
Brand
Platform Hooded Acetabular Insert Trial
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
1228.50.032
Device description
Hooded Acetabular Insert Trial, 32mm head, size 50mm
Published
2022-09-28
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

Contact Domains

Product Codes

CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810094690052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094690052008100946900528100946900520810094690052

GMDN Terms

TermDefinition
Acetabulum prosthesis trial, prefabricated, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

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

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(801)486-6070udi@tjoinc.com

Regulatory Flags

DUNS number
078416717
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00810094692674Klassic Knee Template, Tibial Baseplate, Revision2909.00.0002026-01-07
00810094692476Narrow Distal Femur Cut BlockSRI-100472025-08-27
00810094692544Klassic ONE Universal Cone & Revision Baseplate Tray, Baseplate Insert2417.00.2002025-07-28
00810094692339Acetabular Reamer AdapterSRI-100442025-06-26
00810094691790Klassic Knee Templates, Stem Extensions2806.00.0002025-05-14
00810094692322Spline Wrench, Closed2017.00.1002025-05-14
00810094692346Intramedullary Reamer, Revision2026.10.0002025-05-14
00810094692353Intramedullary Reamer, Revision2026.11.0002025-05-14
00810094692360Intramedullary Reamer, Revision2026.12.0002025-05-14
00810094692377Intramedullary Reamer, Revision2026.13.0002025-05-14
00810094692384Intramedullary Reamer, Revision2026.14.0002025-05-14
00810094692391Intramedullary Reamer, Revision2026.15.0002025-05-14
00810094692407Intramedullary Reamer, Revision2026.16.0002025-05-14

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