FDA.reportPublic FDA data

NA

Primary DI
10885862038517
Brand
NA
Company
Exactech, Inc.
Model
181-03-01
Catalog number
181-03-01
Device description
ADAPTOR, LINER DRIVER, KEYED, 40°
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
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071676000EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGSExactech, Inc.2007-07-19KWZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862038517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586203851710885862038517

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument adaptor, reusableA connecting device designed to join an implant to a surgical instrument or a surgical instrument to another instrument particularly to create an extension or to connect two devices where the interfaces of the devices are not compatible. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This device can be used, e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve. 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
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
07613153071273RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071297RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071310RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071327RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071341RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071389RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071402RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071419RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071426RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071433RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071440RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071587RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071594RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071600RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071617RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071648RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071655RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153072867TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072874TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072881TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072898TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072904TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072911TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072928TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072935TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072942TridentHowmedica Osteonics Corp.KWZ2015-09-24