FDA.reportPublic FDA data

Novation

Primary DI
10885862661500
Brand
Novation
Company
Exactech, Inc.
Model
181-03-13
Catalog number
181-03-13
Device description
Inserter, Constraining Ring
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
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
10885862661500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586266150010885862661500

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

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
09348215154332World Cup G-Zero Liner - Size 32ASIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-06-26
09348215154356World Cup G-Zero Liner - Size 36BSIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-06-26
09348215154363World Cup G-Zero Liner - Size 36CSIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-06-26
09348215154370World Cup G-Zero Liner - Size 36DSIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-06-26
00885556321942REDAPTSmith & Nephew, Inc.KWZ2016-02-24
00885556321393REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321492REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321591REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321690REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321744REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321843REDAPTSmith & Nephew, Inc.KWZ2015-12-11
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