FDA.report

AcuMatch

Primary DI
10885862639622
Company
Exactech, Inc.
Model
103-00-01
Catalog number
103-00-01
Device description
Impactor, Unipolar 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
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
157565946
Device count
1
DM exempt
false
Premarket exempt
false
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
10885862639622PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
10885862639622PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2Orthopedic888.3390YEligible

Premarket Submissions

SubmissionSupplement
K010081000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K010081000ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESISExactech, Inc.2001-02-05KWY

GMDN Terms

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

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

No records found.

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10885862648297Equinoxe313-25-50313-25-502026-03-19

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