FDA.reportPublic FDA data

NA

Primary DI
10885862038296
Brand
NA
Company
Exactech, Inc.
Model
181-00-10
Catalog number
181-00-10
Device description
IMPACTOR ALIGNMENT GUIDE, GROUP 0
Published
2022-08-25
Public version status
Update
Distribution status
Not 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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070479000
K071676000
K100269000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070479000EXACTECH NOVATION CROWN CUP AND LINERSExactech, Inc.2007-03-15LZO
K071676000EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGSExactech, Inc.2007-07-19KWZ
K100269000NOVATION CROWN CUP GXL LINERSExactech, Inc.2010-05-27LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862038296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586203829610885862038296

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
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
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812142InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812142InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01