FDA.reportPublic FDA data

Novation

Primary DI
10885862038609
Brand
Novation
Company
Exactech, Inc.
Model
181-16-00
Catalog number
181-16-00
Device description
LINER EXTRACTOR, NOVATION
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
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
OQIHip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented

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
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032964000
K040601000
K041906000
K050398000
K051556000
K051682000
K060107000
K071676000
K121392000
K173583000
K182502000
K993082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032964000EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTSExactech, Inc.2003-11-13LPH
K040601000EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERSExactech, Inc.2004-10-04KWZ
K041906000EXACTECH 12/14 TOTAL HIP SYSTEMExactech, Inc.2004-09-10LPH
K050398000EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADSExactech, Inc.2005-11-18LZO
K051556000ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENEExactech, Inc.2005-09-06LPH
K051682000EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MMExactech, Inc.2005-07-19LZO
K060107000MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADSExactech, Inc.2006-02-06LZO
K071676000EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGSExactech, Inc.2007-07-19KWZ
K121392000NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREEExactech, Inc.2013-01-16LZO
K173583000Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.2018-03-12OQI
K182502000Alteon Acetabular Cup SystemExactech, Inc.2019-03-13LPH
K993082000EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENTExactech, Inc.1999-11-19LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862038609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586203860910885862038609

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
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