FDA.reportPublic FDA data

EXp Tibial Inserts and Patellar Components

Primary DI
10840843110330
Brand
EXp Tibial Inserts and Patellar Components
Company
GLOBUS MEDICAL, INC.
Model
SC3425-4-26
Published
2015-02-18
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
10840843110330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084084311033010840843110330

GMDN Terms#

Term, Definition table
TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

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
00849044040517N/A632.3002016-01-23
00193982662295ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00012026-03-30
00193982662301ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00022026-03-30
00193982662318ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00032026-03-30
00193982662325ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00502026-03-30
00193982662332ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00702026-03-30
00193982662349ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00902026-03-30
00193982662356ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10502026-03-30
00193982662363ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10702026-03-30
00193982662370ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10902026-03-30
00193982662387ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20502026-03-30
00193982662394ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20902026-03-30
00193982677411ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20702026-03-30
00193982622312EXCELSIUSGPS6252.00482026-03-24
00193982622329EXCELSIUSGPS6252.00492026-03-24
00889095366631EXCELSIUS GPS6143.27022019-07-31
00889095740912EXCELSIUS GPS6143.25422018-06-27
00889095782455CREO6200.10902019-07-31
00889095782462CREO6200.10952019-07-31
00889095782479CREO6200.14002019-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09348215100117TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100124TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100131TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100148TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100155TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100162TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100179TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100186TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100193TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100209TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100216TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100223TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100230TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100247TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100254TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100261TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100278TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100285TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100292TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100308TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100315TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100322TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100339TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100346TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100353TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100360TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100377TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13
09348215100384TriVerse Femoral Component CRSIGNATURE ORTHOPAEDICS PTY LTDOIY2023-01-13