FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327306293
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
I-K2380CG05
Catalog number
I-K2380CG05
Device description
SPECIALTY TRIATHLON BOX CUT GUIDE-NO FEET
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
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327306293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327306293076133273062937613327306293

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth2Millimeter
Device Size Text, specify0

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
07613327259797INSTRUMENT1100-2800R1100-2800R2016-09-24
07613327138078SOLAR5351-41085351-41082015-09-24
04546540167415EXETER0942-2-1100942-2-1102015-09-24
04546540167422EXETER0942-2-1120942-2-1122015-09-24
04546540167439EXETER0942-2-1140942-2-1142015-09-24
04546540167446EXETER0942-2-1160942-2-1162015-09-24
04546540167453EXETER0942-2-1180942-2-1182015-09-24
04546540167460EXETER0942-2-1200942-2-1202015-09-24
07613327245158INSTRUMENT6543-4-8186543-4-8182017-11-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327670936TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327670950TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327670974TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327670981TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671032TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671049TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671056TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671094TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671100TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671131TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671148TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671186TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671209TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671216TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671230TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671247TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671254TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671261TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671278TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671285TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671315TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671322TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671346TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671377TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671384TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671407TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671421TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671445TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671469TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671483TriathlonHowmedica Osteonics Corp.MBH2026-02-26