FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327385403
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
I-K4049FS02
Catalog number
I-K4049FS02
Device description
Specialty Triathlon TS Seating Instrument
Published
2017-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327385403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327385403076133273854037613327385403

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058311945
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26
07613327648485Instrument5533-T-816-R5533-T-816-R2026-02-26
07613327648492Instrument5533-T-814-L5533-T-814-L2026-02-26
07613327651485Instrument5533-T-010-R5533-T-010-R2026-02-26
07613327651492Instrument5533-T-012-R5533-T-012-R2026-02-26
07613327651508Instrument5533-T-016-R5533-T-016-R2026-02-26
07613327651515Instrument5533-T-011-L5533-T-011-L2026-02-26
07613327651522Instrument5533-T-014-L5533-T-014-L2026-02-26
07613327651539Instrument5533-T-009-L5533-T-009-L2026-02-26
07613327651546Instrument5533-T-016-L5533-T-016-L2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327501810INSTRUMENTHowmedica Osteonics Corp.NPJ2022-12-20
07613327546415INSTRUMENTHowmedica Osteonics Corp.NPJ2022-09-09
M572BKA1111111021iDuo Conformis, Inc.NPJ2022-08-17
07613327575880SPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SIZE 7 LEFTHowmedica Osteonics Corp.NPJ2022-02-21
07613327576108SPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SIZE 8 RIGHTHowmedica Osteonics Corp.NPJ2022-02-21
07613327576115SPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SIZE 1 RIGHTHowmedica Osteonics Corp.NPJ2022-02-21
07613327576122SPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SIZE 2 RIGHTHowmedica Osteonics Corp.NPJ2022-02-21
07613327576290SPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SIZE 4 RIGHTHowmedica Osteonics Corp.NPJ2022-02-21
07613327576306SPECIALTY TRIATHLON TS TRIAL ASSESSMENT GUIDE SIZE 8 LEFTHowmedica Osteonics Corp.NPJ2022-02-21
07613327504293Specialty Triathlon Femoral Sizing Feet-RightHowmedica Osteonics Corp.NPJ2021-09-28
07613327504316Specialty Femoral Sizing BodyHowmedica Osteonics Corp.NPJ2021-09-28
M572PAB0113207021iDuo® PatellaConformis, Inc.NPJ2019-09-27
M572PAB0113508021iDuo® PatellaConformis, Inc.NPJ2019-09-27
07613327484045INSTRUMENTHowmedica Osteonics Corp.NPJ2019-06-14
07613327484069INSTRUMENTHowmedica Osteonics Corp.NPJ2019-06-14
07613327467710INSTRUMENTHowmedica Osteonics Corp.NPJ2019-05-03
07613327314809TriathlonHowmedica Osteonics Corp.NPJ2019-01-22
07613327315028TriathlonHowmedica Osteonics Corp.NPJ2019-01-22
07613327315165TriathlonHowmedica Osteonics Corp.NPJ2019-01-22
07613327315196TriathlonHowmedica Osteonics Corp.NPJ2019-01-22
07613327315349TriathlonHowmedica Osteonics Corp.NPJ2019-01-22
07613327315424TriathlonHowmedica Osteonics Corp.NPJ2019-01-22
07613327315448TriathlonHowmedica Osteonics Corp.NPJ2019-01-22
07613327315493TriathlonHowmedica Osteonics Corp.NPJ2019-01-22
07613327315523TriathlonHowmedica Osteonics Corp.NPJ2019-01-22
07613327315721TriathlonHowmedica Osteonics Corp.NPJ2019-01-22
07613327315844TriathlonHowmedica Osteonics Corp.NPJ2019-01-22
07613327328561INSTRUMENTHowmedica Osteonics Corp.NPJ2018-09-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24