FDA.reportPublic FDA data

AcuMatch

Primary DI
10885862660541
Brand
AcuMatch
Company
Exactech, Inc.
Model
103-61-07
Catalog number
103-61-07
Device description
Trial Adaptor, Unipolar, O-Ring
Published
2026-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862660541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586266054110885862660541

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head prosthesis trialA copy of a final femoral head prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size, and to help achieve the desired offset, leg-length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral stem trial or final prostheses; some may be used with explantation instruments during removal of implanted acetabulum cups. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00840286853163TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286853170TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286853187TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286855587TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286855921TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859929TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859943TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859967TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859974TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859981TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859998TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860000TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860123Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860130Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860222Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860444Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860468Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860482Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860505Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860529Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860543Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860567Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860581Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860604Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00889024701281Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701298Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701304Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701311Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701328Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701335Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10