FDA.reportPublic FDA data

Truliant CC

Primary DI
10885862627445
Brand
Truliant CC
Company
Exactech, Inc.
Model
02-019-30-0202
Catalog number
02-019-30-0202
Device description
TRULIANT TIBIAL OFFSET PREP REAMER
Published
2023-11-09
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
10885862627445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586262744510885862627445

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. 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
10885862657244Equinoxe330-36-00330-36-002026-07-07
10885862657251Equinoxe330-36-03330-36-032026-07-07
10885862657268Equinoxe330-36-10330-36-102026-07-07
10885862657275Equinoxe330-36-13330-36-132026-07-07
10885862657282Equinoxe330-38-00330-38-002026-07-07
10885862657299Equinoxe330-38-03330-38-032026-07-07
10885862657305Equinoxe330-38-10330-38-102026-07-07
10885862657312Equinoxe330-38-13330-38-132026-07-07
10885862657329Equinoxe330-40-00330-40-002026-07-07
10885862657336Equinoxe330-40-03330-40-032026-07-07
10885862657343Equinoxe330-40-10330-40-102026-07-07
10885862657350Equinoxe330-40-13330-40-132026-07-07
10885862657367Equinoxe330-42-00330-42-002026-07-07
10885862657374Equinoxe330-42-03330-42-032026-07-07
10885862657381Equinoxe330-42-10330-42-102026-07-07
10885862657398Equinoxe330-42-13330-42-132026-07-07
10885862657442Equinoxe330-46-00330-46-002026-07-07
10885862657459Equinoxe330-46-03330-46-032026-07-07
10885862657466Equinoxe330-46-10330-46-102026-07-07
10885862657473Equinoxe330-46-13330-46-132026-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556923023NASmith & Nephew, Inc.JWH2026-07-16
08800017262819EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262826EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262833EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262840EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262857EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262864EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262871EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262888EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262895EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262901EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262918EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262925EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262932EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262949EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262956EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262963EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262970EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262987EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262994EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263007EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263014EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263021EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263038EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263045EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263052EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263069EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263076EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263083EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263090EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10