FDA.reportPublic FDA data

NA

Primary DI
10885862038326
Brand
NA
Company
Exactech, Inc.
Model
181-00-13
Catalog number
181-00-13
Device description
IMPACTOR ALIGNMENT GUIDE, GROUP 3
Published
2022-08-25
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
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
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
K070479000
K071676000
K100269000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070479000EXACTECH NOVATION CROWN CUP AND LINERSExactech, Inc.2007-03-15LZO
K071676000EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGSExactech, Inc.2007-07-19KWZ
K100269000NOVATION CROWN CUP GXL LINERSExactech, Inc.2010-05-27LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862038326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586203832610885862038326

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

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
04046964680878COREHIP EXTENDEDAesculap AGLZO2020-08-10
04046964681028COREHIP EXTENDEDAesculap AGLZO2020-08-10
04046964681127COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681189COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681301COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681349COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681363COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681387COREHIP PRIMARYAesculap AGLZO2020-08-10
04046964681400COREHIP PRIMARYAesculap AGLZO2020-08-10
04546540035523OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035523OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035523OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035714OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035714OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035714OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035790OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035790OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035790OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035806OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035806OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035806OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035813OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035813OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035813OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035820OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035820OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035820OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035837OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035837OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035837OmnifitHowmedica Osteonics Corp.LPH2015-09-24