FDA.reportPublic FDA data

N/A

Primary DI
10885862660657
Brand
N/A
Company
Exactech, Inc.
Model
141-01-32
Catalog number
141-01-32
Device description
Liner Driver Head
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
10885862660657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586266065710885862660657

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter32Millimeter

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
10885862660527AcuMatch103-61-00103-61-002026-05-28
10885862660541AcuMatch103-61-07103-61-072026-05-28
10885862660558AcuMatch103-61-10103-61-102026-05-28
10885862660565AcuMatch103-61-97103-61-972026-05-28
10885862663207N/A101-14-00101-14-002026-05-28
10885862656117Newton02-521-90-200402-521-90-20042026-05-27
10885862656124Newton02-521-90-200502-521-90-20052026-05-27
10885862656131Newton02-521-90-200602-521-90-20062026-05-27
10885862656148Newton02-521-90-200702-521-90-20072026-05-27
10885862656155Newton02-521-90-200802-521-90-20082026-05-27
10885862656162Newton02-521-90-200902-521-90-20092026-05-27
10885862656179Newton02-521-90-201002-521-90-20102026-05-27
10885862653697Alteon190-00-01190-00-012026-05-26
10885862653703Alteon190-00-02190-00-022026-05-26
10885862653710Alteon190-00-03190-00-032026-05-26
10885862653727Alteon190-00-04190-00-042026-05-26
10885862653734Alteon190-00-05190-00-052026-05-26
10885862653741Alteon190-00-06190-00-062026-05-26
10885862653758Alteon190-00-07190-00-072026-05-26
10885862653765Alteon190-00-08190-00-082026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048844017309NAimplantcast GmbHOQI2026-06-02
04048844708443EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711597EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711726EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711740EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711795EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711870EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711917EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711955EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711979EPORE® XOimplantcast GmbHOQI2026-06-02
04048844712020EPORE® XOimplantcast GmbHOQI2026-06-02
04048844712068EPORE® XOimplantcast GmbHOQI2026-06-02
04048844712099EPORE® XOimplantcast GmbHOQI2026-06-02
04048844712723NAimplantcast GmbHOQI2026-06-02
04048844712747NAimplantcast GmbHOQI2026-06-02
04048844712761NAimplantcast GmbHOQI2026-06-02
04048844712785NAimplantcast GmbHOQI2026-06-02
04048844712808NAimplantcast GmbHOQI2026-06-02
04048844712822NAimplantcast GmbHOQI2026-06-02
04048844712846NAimplantcast GmbHOQI2026-06-02
04048844712860NAimplantcast GmbHOQI2026-06-02
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQI2026-06-01
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQI2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQI2026-06-01