FDA.reportPublic FDA data

Modal Total Hip System

Primary DI
B035M132536021
Brand
Modal Total Hip System
Company
MODAL MANUFACTURING LLC
Model
M-1325-3602
Device description
Femoral Head, Ceramic Sz 36 M
Published
2018-07-01
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

Product Codes#

Code, Name table
CodeName
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B035M132536021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic-on-polyethylene total hip prosthesisA sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a ceramic-on-polyethylene or cross-linked polyethylene (PE) interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081983825
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B035M322050561Modal Total Knee SystemRev AM-3220-50562021-05-27
B035CPM32024005N0Modal Total Knee SystemRev ACPM-3202-4005-N2021-05-25
B035CPM32024105N0Modal Total Knee SystemRev ACPM-3202-4105-N2021-05-25
B035CPM32024205N0Modal Total Knee SystemRev ACPM-3202-4205-N2021-05-25
B035CPM32024305N0Modal Total Knee SystemRev ACPM-3202-4305-N2021-05-25
B035CPM32024405N0Modal Total Knee SystemRev ACPM-3202-4405-N2021-05-25
B035CPM32024505N0Modal Total Knee SystemRev ACPM-3202-4505-N2021-05-25
B035CPM32024605N0Modal Total Knee SystemRev ACPM-3202-4605-N2021-05-25
B035G9101000Modal Total Knee SystemRev BG9101002021-03-17
B035M312050310Modal Total Knee SystemRev FM-3120-50312020-10-15
B035M312050320Modal Total Knee SystemRev FM-3120-50322020-10-15
B035M322050160Modal Total Knee SystemRev CM-3220-50162020-10-15
B035M322050531Modal Total Knee SystemRev BM-3220-50532020-10-15
B035M341101001Modal Total Knee SystemRev DM-3411-01002020-10-15
B035M342050411Modal Total Knee SystemRev AM-3420-50412020-10-15
B035M332050540Modal Total Knee SystemRev AM-3320-50542020-09-03
B035M31205030011Modal Total Knee SystemRev BM-3120-5030-012020-06-26
B035M312050301Modal Total Knee SystemRev BM-3120-50302020-06-26
B035M31205050011Modal Total Knee SystemRev AM-3120-5050-012020-06-26
B035M31205050021Modal Total Knee SystemRev AM-3120-5050-022020-06-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04048844732042implaFit®implantcast GmbHLZO2026-03-20
04048844732059implaFit®implantcast GmbHLZO2026-03-20
04048844732080implaFit®implantcast GmbHLZO2026-03-20
04048844732097implaFit®implantcast GmbHLZO2026-03-20
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10885862660329N/AExactech, Inc.LZO2026-03-19