FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327409796
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
I-K39600618
Catalog number
I-K39600618
Device description
SPECIALTY TRIATHLON GAP GAGE
Published
2018-05-03
Public version status
New
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
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327409796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327409796076133274097967613327409796

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
Device Size Text, specify0
Device Size Text, specify0

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
EPIS18100PF0Episealer Knee Revision GuideEpisurf Operations ABKRR2023-07-24
EPIS31120PF0Femoral ComponentEpisurf Operations ABKRR2023-07-24
EPIS31125PF0Femoral ComponentEpisurf Operations ABKRR2023-07-24
EPIS31129PF0Femoral ComponentEpisurf Operations ABKRR2023-07-24
EPIS32120PF0Femoral EpidrillEpisurf Operations ABKRR2023-07-24
EPIS32125PF0Femoral EpidrillEpisurf Operations ABKRR2023-07-24
EPIS32129PF0Femoral EpidrillEpisurf Operations ABKRR2023-07-24
EPIS33120PF0Femoral Drilling SocketEpisurf Operations ABKRR2023-07-24
EPIS33125PF0Femoral Drilling SocketEpisurf Operations ABKRR2023-07-24
EPIS33129PF0Femoral Drilling SocketEpisurf Operations ABKRR2023-07-24
EPIS33420PF0Femoral Adjustment SocketEpisurf Operations ABKRR2023-07-24
EPIS33425PF0Femoral Adjustment SocketEpisurf Operations ABKRR2023-07-24
EPIS33429PF0Femoral Adjustment SocketEpisurf Operations ABKRR2023-07-24
EPIS33720PF0Femoral EpiguideEpisurf Operations ABKRR2023-07-24
EPIS33725PF0Femoral EpiguideEpisurf Operations ABKRR2023-07-24
EPIS33729PF0Femoral EpiguideEpisurf Operations ABKRR2023-07-24
EPIS34120PF0Femoral EpidummyEpisurf Operations ABKRR2023-07-24
EPIS34125PF0Femoral EpidummyEpisurf Operations ABKRR2023-07-24
EPIS34129PF0Femoral EpidummyEpisurf Operations ABKRR2023-07-24
EPIS37320PF0Femoral EpimandrelEpisurf Operations ABKRR2023-07-24
EPIS37325PF0Femoral EpimandrelEpisurf Operations ABKRR2023-07-24
EPIS37329PF0Femoral EpimandrelEpisurf Operations ABKRR2023-07-24
EPIS51117PF0Femoral ComponentEpisurf Operations ABKRR2023-07-24
EPIS51120PF0Femoral ComponentEpisurf Operations ABKRR2023-07-24
EPIS51125PF0Femoral ComponentEpisurf Operations ABKRR2023-07-24
EPIS52117PF0Femoral EpidrillEpisurf Operations ABKRR2023-07-24
EPIS52120PF0Femoral EpidrillEpisurf Operations ABKRR2023-07-24
EPIS52125PF0Femoral EpidrillEpisurf Operations ABKRR2023-07-24
EPIS53117PF0Femoral Drilling SocketEpisurf Operations ABKRR2023-07-24
EPIS53120PF0Femoral Drilling SocketEpisurf Operations ABKRR2023-07-24