FDA.reportPublic FDA data

N/A

Primary DI
10885862660596
Brand
N/A
Company
Exactech, Inc.
Model
121-01-04
Catalog number
121-01-04
Device description
Liner Driver Head, Impactor, Adaptor
Published
2026-03-19
Public version status
New
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
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS 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
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous 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
K173583000
K182502000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173583000Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.2018-03-12OQI
K182502000Alteon Acetabular Cup SystemExactech, Inc.2019-03-13LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862660596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586266059610885862660596

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). 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
10885862032102Novation160-20-11160-20-112015-08-10
10885862064035Optetrak244-24-09244-24-092015-10-30
10885862307132Truliant02-022-49-251102-022-49-25112017-05-16
10885862313058Optetrak Logic02-012-44-260902-012-44-26092017-02-16
10885862313065Optetrak Logic02-012-44-261102-012-44-26112017-02-16
10885862313072Optetrak Logic02-012-44-261302-012-44-26132017-02-16
10885862313089Optetrak Logic02-012-44-261502-012-44-26152017-02-16
10885862313218Optetrak Logic02-012-35-210902-012-35-21092017-02-16
10885862313225Optetrak Logic02-012-35-211102-012-35-21112017-02-16
10885862313232Optetrak Logic02-012-35-211302-012-35-21132017-02-16
10885862316271Optetrak Logic02-012-35-211702-012-35-21172017-02-16
10885862316288Optetrak Logic02-012-35-211902-012-35-21192017-02-16
10885862316356Optetrak Logic02-012-44-261702-012-44-26172017-02-16
10885862316363Optetrak Logic02-012-44-261902-012-44-26192017-02-16
10885862135049NAT2-5052T2-50522022-09-19
10885862135056NAT2-5458T2-54582022-09-19
10885862135063NAT2-6064T2-60642022-09-19
10885862135070NAT2-6670T2-66702022-09-19
10885862135636NAT8-4448T8-44482022-09-19
10885862135643NAT8-5052T8-50522022-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630542796555Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796562Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796579Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796586Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796593Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796609Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796616Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796623Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796630Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796647Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796654Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796661Mfinity Femoral SystemMedacta International SAMEH2026-08-25
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
05056139247293Icona Hip StemCORIN LTDMEH2025-04-07
10885862015181AuraExactech, Inc.JDI2022-10-04
10885862015198AuraExactech, Inc.JDI2022-10-04
10885862015204AuraExactech, Inc.JDI2022-10-04
10885862015211AuraExactech, Inc.JDI2022-10-04
10885862013743NAExactech, Inc.JDI2022-09-20
10885862013743NAExactech, Inc.LPH2022-09-20
10885862013750NAExactech, Inc.JDI2022-09-20
10885862013750NAExactech, Inc.LPH2022-09-20
10885862010551NAExactech, Inc.LPH2022-08-18
10885862010551NAExactech, Inc.JDI2022-08-18
10885862010575NAExactech, Inc.LPH2022-08-18
10885862010575NAExactech, Inc.JDI2022-08-18
10885862010582NAExactech, Inc.JDI2022-08-18
10885862010582NAExactech, Inc.LPH2022-08-18
10885862010872NAExactech, Inc.LPH2022-08-18
10885862010872NAExactech, Inc.JDI2022-08-18