FDA.reportPublic FDA data

NA

Primary DI
10885862257345
Brand
NA
Company
Exactech, Inc.
Model
01-003-04-0002
Catalog number
01-003-04-0002
Device description
BLADE, CALCAR PLANER
Published
2022-07-28
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
KWLProsthesis, hip, hemi-, femoral, metal
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140674000
K162732000
K182462000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140674000EXACTECH TAPERED WEDGE FEMORAL STEMExactech, Inc.2014-06-30LZO
K162732000Exactech® Alteon® HA Femoral StemExactech, Inc.2017-04-26MEH
K182462000Exactech Alteon Highly Polished Femoral StemExactech, Inc.2018-11-08LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862257345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586225734510885862257345

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy in varying sizes. 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
04546540035523OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035523OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035523OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035714OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035714OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035714OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035790OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035790OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035790OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035806OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035806OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035806OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035813OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035813OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035813OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035820OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035820OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035820OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035837OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035837OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035837OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
07613327016772UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016789UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016796UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016802UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016819UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016826UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016833UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016840UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016857UHRHowmedica Osteonics Corp.KWL2015-09-24