FDA.reportPublic FDA data

Truliant CC

Primary DI
10885862625892
Brand
Truliant CC
Company
Exactech, Inc.
Model
02-011-06-0493
Catalog number
02-011-06-0493
Device description
TRULIANT DIST. AUG. BLOCK TRIAL SZ 3-5, 15MM
Published
2023-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150890000Exactech Optetrak Logic CCExactech, Inc.2015-05-29JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862625892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586262589210885862625892

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur prosthesis trial, reusableA copy of a final femur prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes femoral articulation trials, femoral spacer trials, femoral wedge/augment trials, anterior stop trials, stem adaptor trials, and stem trials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862094780OpteCure650-00-01650-00-012016-07-17
10885862094797OpteCure650-00-02650-00-022016-07-17
10885862094803OpteCure650-00-05650-00-052016-06-17
10885862094810OpteCure650-00-10650-00-102016-07-17
10885862094827Optecure650-00-20650-00-202016-09-19
10885862094841OpteCure+CCC652-00-01652-00-012016-07-17
10885862094858OpteCure+CCC652-00-02652-00-022016-07-17
10885862094865OpteCure+CCC652-00-05652-00-052016-07-17
10885862094872OpteCure+CCC652-00-10652-00-102016-07-17
10885862094889OpteCure+CCC652-00-20652-00-202016-07-17
10885862095039Ossigen660-00-20660-00-202016-07-17
10885862252593Entice +CCC692-00-01692-00-012016-07-17
10885862252609Entice +CCC692-00-02692-00-022016-07-17
10885862252616Entice +CCC692-00-05692-00-052016-07-17
10885862252623Entice +CCC692-00-10692-00-102016-07-17
10885862252630Entice +CCC692-00-20692-00-202016-07-17
10885862252845Entice690-00-01690-00-012016-07-17
10885862252852Entice690-00-02690-00-022016-07-17
10885862252869Entice690-00-05690-00-052016-07-17
10885862252876Entice690-00-10690-00-102016-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247712Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247729Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247736Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247743Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247767Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247774Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247781Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247798Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247897Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247903Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247910Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247927Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247934Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139247996Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248009Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248016Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248023Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248030Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248108Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248115Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248122Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248139Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248191Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248207Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248214Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248221Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248238Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248290Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248306Unity Total Knee SystemCORIN LTDJWH2026-10-19
05056139248313Unity Total Knee SystemCORIN LTDJWH2026-10-19