FDA.report

Mpact Acetabular System

Primary DI
07630345798671
Brand
Mpact Acetabular System
Company
Medacta International SA
Model
01.32.144SHT
Device description
Acetabular shell Ø44 No-hole T
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions

SubmissionSupplement
K230011000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230011000Mpact ExtensionMedacta International S.A.2023-09-20LPH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630345798671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630345798671076303457986717630345798671

GMDN Terms

TermDefinition
Acetabular shellAn implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Sterilization Methods

Method

Regulatory Flags

DUNS number
488227125
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07630699705523Surgical Manual Instrument02.12.10.31662026-03-19
07630542725562Surgical Manual Instrument01.10.10.11602026-03-17
07630542791482Spine Instruments03.75.10.06612026-03-13
07630971230880Surgical Manual Instrument03.51.10.02342026-03-02
07630542790799Mfinity Femoral System01.24.10.3002026-02-27
07630542790805Mfinity Femoral System01.24.10.3012026-02-27
07630542790812Mfinity Femoral System01.24.10.3022026-02-27
07630542790829Mfinity Femoral System01.24.10.3032026-02-27

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Primary DIBrandCompanyProduct codePublished
10885862660633N/AExactech, Inc.LPH2026-03-19
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04580810068705Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068712Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068729Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
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04580810068743Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
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04580810068804Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
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