FDA.reportPublic FDA data

EXp Tibial Inserts and Patellar Components

Primary DI
10840843110613
Brand
EXp Tibial Inserts and Patellar Components
Company
GLOBUS MEDICAL, INC.
Model
SC3426-29
Device description
Single Peg Patella, EXp
Published
2015-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840843110613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084084311061310840843110613

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene patella prosthesisAn artificial kneecap (patellar component) made of polyethylene (PE) and implanted during primary or revision bicondylar knee joint replacement. It is a sterile device designed to articulate with a prosthetic distal femoral component and is implanted on the back of the natural patella with bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
139105691
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193982572983CREO6120.50866120.50862026-06-10
00193982586393CAPTIVATE3188.25113188.25112026-06-10
00193982586416CAPTIVATE3188.25133188.25132026-06-10
00193982586430CAPTIVATE3188.25153188.25152026-06-10
00193982586454CAPTIVATE3188.25173188.25172026-06-10
00193982586478CAPTIVATE3188.25193188.25192026-06-10
00193982586690CAPTIVATE3188.26143188.26142026-06-10
00193982586706CAPTIVATE3188.26153188.26152026-06-10
00193982586713CAPTIVATE3188.26163188.26162026-06-10
00193982586720CAPTIVATE3188.26173188.26172026-06-10
00193982586737CAPTIVATE3188.26183188.26182026-06-10
00193982586744CAPTIVATE3188.26193188.26192026-06-10
00193982586973CAPTIVATE3188.30113188.30112026-06-10
00193982586997CAPTIVATE3188.30133188.30132026-06-10
00193982587017CAPTIVATE3188.30153188.30152026-06-10
00193982587031CAPTIVATE3188.30173188.30172026-06-10
00193982587055CAPTIVATE3188.30193188.30192026-06-10
00193982587277CAPTIVATE3188.31143188.31142026-06-10
00193982587284CAPTIVATE3188.31153188.31152026-06-10
00193982587291CAPTIVATE3188.31163188.31162026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843575106445MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106452MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106469MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106476MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106483MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106490MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106506MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106513MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106520MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106537MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106544MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106551MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106568MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106575MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106582MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575106599MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107619MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107626MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107633MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107640MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107657MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107664MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107671MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107688MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107695MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107701MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107718MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107725MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107732MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29
00843575107749MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.OIY2026-05-29