FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327195613
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
6541-4-817
Catalog number
6541-4-817
Device description
TRIATHLON ALL POLY TIBIA IMPACTOR
Published
2016-09-24
Public version status
Update
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
K123166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123166000TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (PHowmedica Osteonics Corp.2013-02-14JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327195613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327195613076133271956137613327195613

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327012804V40 Head6260-4-2226260-4-2222015-09-24
07613327012811V40 Head6260-4-3226260-4-3222015-09-24
07613327012828V40 Head6260-5-0266260-5-0262015-09-24
07613327012835V40 Head6260-5-0286260-5-0282015-09-24
07613327012842V40 Head6260-5-0326260-5-0322015-09-24
07613327012859V40 Head6260-5-1266260-5-1262015-09-24
07613327012866V40 Head6260-5-1286260-5-1282015-09-24
07613327012873V40 Head6260-5-1326260-5-1322015-09-24
07613327012880V40 Head6260-5-2266260-5-2262015-09-24
07613327012897V40 Head6260-5-2286260-5-2282015-09-24
07613327012903V40 Head6260-5-2326260-5-2322015-09-24
07613327012941V40 Head6260-5-4266260-5-4262015-09-24
07613327012958V40 Head6260-5-4286260-5-4282015-09-24
07613327012965V40 Head6260-5-4326260-5-4322015-09-24
07613327012972V40 Head6260-5-6286260-5-6282015-09-24
07613327019704Restoration5096-46255096-46252015-09-24
07613327019711Restoration5096-46155096-46152015-09-24
07613327019728Restoration5096-46205096-46202015-09-24
07613327019735Restoration5096-50155096-50152015-09-24
07613327019742Restoration5096-50205096-50202015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536705Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536712Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536781Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536798Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
E31442411410SignatureMaterialise NVJWH2026-09-24
E31442422415SignatureMaterialise NVJWH2026-09-24
E31442422450SignatureMaterialise NVJWH2026-09-24
E31442422451SignatureMaterialise NVJWH2026-09-24
E31442422452SignatureMaterialise NVJWH2026-09-24
E31442422453SignatureMaterialise NVJWH2026-09-24
E31442422455SignatureMaterialise NVJWH2026-09-24
E31442422456SignatureMaterialise NVJWH2026-09-24
E31442422457SignatureMaterialise NVJWH2026-09-24
E31442422458SignatureMaterialise NVJWH2026-09-24
E31442422460SignatureMaterialise NVJWH2026-09-24
E31442422461SignatureMaterialise NVJWH2026-09-24
E31442422462SignatureMaterialise NVJWH2026-09-24
E31442422463SignatureMaterialise NVJWH2026-09-24
E31442422465SignatureMaterialise NVJWH2026-09-24
E31442422466SignatureMaterialise NVJWH2026-09-24
E31442422467SignatureMaterialise NVJWH2026-09-24
E31442422468SignatureMaterialise NVJWH2026-09-24